The Safety and Effectiveness of NEPA in Preventing Postoperative Nausea and Vomiting After General Anesthesia Gastrointestinal Cancer Surgery: A Single-Center Retrospective Study

The rapid progress of multiple antiemetic regimens ensures that patients can receive full dose chemotherapy, however, there are still a large number of unmet clinical needs in patient evaluation and treatment. Due to the fact that patients with liver, gallbladder, and pancreatic diseases undergoing surgery are still in the stage of nausea and vomiting, the actual incidence of delayed nausea and vomiting may be underestimated. The long-term effective control of nausea and vomiting by Nitopitan Palonosetron capsules may improve the quality of life of patients during and after treatment, and ultimately improve clinical outcomes

Start Date15 May 2024

Sponsor / Collaborator

Tianjin Cancer Institute

NCT06331520 / Not yet recruitingPhase 3IIT

Dexamethasone-sparing Based on Netupitant/Palonosetron(NEPA) With Olanzapine for the Effect of Chemotherapy-induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Chemotherapy: a Randomized Noninferiority III Phase Trial

The objective of this Prospective, randomized, non inferiority phase III trial is to confirm the efficacy and saftey of dexamethasone-sparing combined with netupitant/palonostron and olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.

Start Date01 May 2024

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Netupitant/Palonosetron Hydrochloride

100 Translational Medicine associated with Netupitant/Palonosetron Hydrochloride

100 Patents (Medical) associated with Netupitant/Palonosetron Hydrochloride

118

Literatures (Medical) associated with Netupitant/Palonosetron Hydrochloride

01 Oct 2024·Medicine & Science in Sports & Exercise

Acute Vigorous Exercise Decreases Subsequent Nonexercise Physical Activity and Body Temperature Linked to Weight Gain

Article

Author: Matsui, Takashi ; DOBASHI, SHOHEI ; Funabashi, Daisuke ; SAMESHIMA, KAZUKI ; MATSUI, TAKASHI ; SAGAYAMA, HIROYUKI ; NISHIJIMA, TAKESHI ; FUNABASHI, DAISUKE

ABSTRACTPurposeExercise benefits the body and mind, but its weight loss effect is less than generally expected. Although this phenomenon is likely due to an exercise intensity–dependent decrease in non-exercise physical activity (NEPA), resulting in a decrease in non-exercise activity thermogenesis, the underlying mechanisms and effects of exercise intensity remain unknown. Here we show that acute vigorous exercise decreases subsequent NEPA and body temperature (BT) in association with body weight gain.MethodsAdult male C57BL/6J mice were categorized into three groups: sedentary, moderate exercise, and vigorous exercise, with exercise groups undergoing a 30-min treadmill session. Using an intraperitoneally implanted activity monitor, NEPA and BT were monitored for 2 d before and 3 d after exercise. The daily synchrony between NEPA and BT was evaluated using a cross-correlation function. Plasma corticosterone was also detected 6 and 24 h after exercise.ResultsNotably, only the vigorous exercise group exhibited a decline in both NEPA and BT, resulting in body weight gain the following day, despite no observed changes in food intake. Furthermore, vigorous exercise induces a distinct delay in the daily dynamics of NEPA compared with BT. A positive correlation was observed between plasma corticosterone levels and changes in NEPA levels before and after exercise across all exercise groups.ConclusionsOur findings provide evidence for vigorous exercise–specific reduction in subsequent NEPA, BT, and their synchrony linked to weight gain, likely due to the disturbed circadian rhythm of corticosterone. This is an initial investigation redefining the significance of exercise intensity in beneficial effects beyond the energy expenditure of the exercise itself.

01 Oct 2024·Journal of Oncology Pharmacy Practice

Assessment of the change of antiemetic prophylaxis from double to triple combination in patients with high dose carboplatin chemotherapy

Article

Author: Carcelero San Martín, Esther ; Rollán, Neus Basté ; Monge-Escartín, Inés ; Pérez Sánchez, Ángela ; Rodríguez Mues, Mª Carmen ; Reguart, Noemí ; Riu-Viladoms, Gisela ; Albanell-Fernández, Marta ; Soy Muner, Dolors ; Gaba García, Lydia ; Corominas Bosch, Mª Lourdes

Introduction Chemotherapy-induced nausea and vomiting (CINV) is one of the adverse events that most affects oncologic patients’ quality of life. Carboplatin AUC ≥ 4 belongs to agents with high emetic risk (moderate risk in ASCO guidelines). We aimed to compare the effectiveness of netupitant/palonosetron and dexamethasone triple combination (TC) therapy versus ondansetron and dexamethasone double combination (DC) therapy as antiemetic prophylaxis in patients with carboplatin AUC ≥ 4. As a secondary endpoint, in TC group we evaluated the effectiveness of changing NEPA administration timing from 1 h to 15 min before chemotherapy. Methods Open-label prospective study conducted in a tertiary-care hospital in patients receiving carboplatin AUC ≥ 4. CINV was evaluated using MASCC antiemetic tool, in acute (<24 h) and delayed phase (24–120 h). Results were analyzed using χ2 test. Results Two-hundred four completed questionnaires (CQ) were analyzed (76 in DC and 128 in TC). The proportion of patients who remained emesis-free was superior for TC-treated group compared to DC, either in acute (99.2% vs 92.1%, p = 0.0115) and delayed phase (97.6% vs 90.7%, p = 0.043). Likewise, a higher proportion of TC-treated patients compared to DC remained nausea-free for the first 24 h after treatment (90.6% vs 71%, p = 0.0004) and between 24 and 120 h (82.3% vs 62.7%, p = 0.0025). The change of NEPA administration time showed similar effectiveness in terms of CINV control (81.6% vs 74.5%, p = 0.70). Conclusions TC showed superiority in early and delayed CINV control in carboplatin AUC ≥ 4 regimens, with no significant differences among cancer types. Change in NEPA administration timing has beneficial implications; it allows NEPA to be administered at hospitals before chemotherapy session.

26 Sep 2024·Cureus

Dexamethasone-Sparing Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting in Highly and Moderately Emetogenic Chemotherapy: The SHEILD Study

Article

Author: Kumar, Suresh B ; Sharma, Suyash B ; Tripathi, Richa ; Kumar Punukollu, Uday ; Venkatesh, Tirumala ; Reddy, Sudheer ; Kumar, Suresh B

BACKGROUNDChemotherapy-induced nausea and vomiting (CINV) significantly impacts patient's quality of life and treatment adherence. This study investigated the efficacy of Generic Netupitant and Palonosetron tablets (Nykron) with dexamethasone single dose for CINV prophylaxis in patients receiving highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Additionally, this approach aligns with the principles of the SHIELD study (Sparing High Efficacy Intervention for Low Dose Dexamethasone), which focuses on maximizing antiemetic effectiveness while minimizing dexamethasone use.METHODOLOGYThis multicenter retrospective study evaluates data from patients who received HEC/MEC and were administered a fixed-dose combination of Generic NEPA (Netupitant 300 mg and Palonosetron 0.5 mg tablets, Nykron combi-pack) along with a single dose of dexamethasone (12 mg/8 mg) before chemotherapy. The data were collected from September 2022 till September 2023. Outcomes measured included complete response (no vomiting and no need for rescue medications), complete protection (no significant nausea (<2.5 cm on VAS), no vomiting, and no use of rescue medication), and complete control (no emetic episodes, no rescue therapy, and no nausea [0 cm on VAS]) during the acute phase (0-24 hours) and delayed phase (24-120 hours) post-chemotherapy.RESULTSThe data of 372 patients was evaluated in which breast cancer was the most common cancer with 223 (59.95%) patients for which doxorubicin and cyclophosphamide (192, 51.61%) was the most administered chemotherapy combination. The second most common cancer was gastrointestinal (GI) cancer with stomach cancer in 47 (12.6%), colorectal cancer in 4 (1%), and pancreatic cancer in 2 (0.54%). A total of 360 (96.8%) patients received an HEC regimen across the cycle, while only 5 (1.3%) received an MEC regimen. The regimen demonstrated exceptional efficacy with a 96.9% overall response rate across all cycles. Complete control rates for acute CINV were 92% and 90% for delayed CINV across chemotherapy cycles. Complete response rates remained consistently high (94%-98%) across all cycles and overall phases. Only 3% of patients experienced anticipatory CINV.CONCLUSIONSThis dexamethasone-sparing Generic NEPA regimen showed remarkable efficacy in CINV management for HEC/MEC regimen-receiving patients, maintaining high response rates in both acute and delayed across all cycles. These findings indicate a potential paradigm shift in CINV prophylaxis, necessitating further investigation through prospective, randomized controlled trials to validate long-term safety and efficacy.

News (Medical) associated with Netupitant/Palonosetron Hydrochloride

07 Nov 2024

·www.prnewswire.com

Fosun Attends CIIE for the Seventh Time - Guo Guangchang: Confident that China's High-Level Openness is a Historical Opportunity

HONG KONG, Nov. 7, 2024 /PRNewswire/ -- On November 5, the 7th China International Import Expo (CIIE) opened at the National Exhibition and Convention Center in Shanghai. As a seven-time attendee of the CIIE, Fosun showcased the latest achievements in innovation and global operations at its Fosun Pharma booth in Hall 7.1, featuring cutting-edge medical devices and innovative pharmaceuticals that made their debut in China. Guo Guangchang, Chairman of Fosun International, remarked, "Over the past seven years, CIIE has improved every year, becoming a window for China to build a new development framework, a platform for high-level openness, and an international public product for global sharing. Fosun has been a participant, witness, and beneficiary of the CIIE. Leveraging the CIIE platform, our long-term innovations have continually been put into practice, transforming many 'exhibits' into 'products', and converting many overseas partners from 'exhibitors' into 'investors'. This year, we continue to showcase our latest achievements in integrated innovation in the medical device and health sector, including several 'world's firsts' and 'China's firsts'. We firmly believe that China remains a significant opportunity for global development. Together with more overseas companies and global partners, we will promote more cutting-edge innovations to take root in China, moving forward and achieving mutual success on the grand stage of the CIIE." Stars of CIIE Taking Root, Transforming Ion from "Exhibit" to "Product" Healthcare is one of Fosun's main businesses. With CIIE's "spillover effect," several star products from Fosun, supported by the CIIE "accelerator" effect, have successfully entered the market to serve Chinese patients, transforming from "exhibits" into "products". This year, following the popular da Vinci Surgical System, the Ion Robotic Bronchoscopy made its CIIE debut after receiving domestic approval. Since its first appearance at the CIIE in 2019, Ion caught the attention of visitors. By the end of 2022, Ion entered the National Medical Products Administration's 'Green Channel' for innovative products and gained approval in March 2024, with the first commercial application completed in September. Lung cancer is considered the leading cause of cancer deaths, with 1.06 million new cases in China in 2022. The five-year survival rate is only 19.7%, and bronchoscopy is a key diagnostic tool for early lung cancer detection. The Ion bronchoscopy navigation control system offers innovative features for precise, convenient clinical diagnosis, providing new options for patients. By the third quarter of this year, 736 Ion systems had been installed globally, with over 150,000 Ion procedures performed. Outside the CIIE exhibition hall, Fosun is accelerating the localization of advanced medical devices. In June this year, Intuitive Fosun's headquarter industrial base was launched in Shanghai, marking Intuitive's largest R&D, production, and training center in the Asia-Pacific region. At this base, in addition to the Ion shape-sensing bronchoscopy control system, advanced products and core components, including the da Vinci surgical robot, are gradually achieving "Made in China, joint R&D, and global sales." Accelerating Integrated Innovation to Lead in Neurological Disease Treatment Transformation Fosun has long committed to investing in cutting-edge areas of healthcare, fostering a continuous stream of breakthrough "solid achievements" through an open innovation ecosystem involving independent R&D, collaborative development, licensing, and industry investment. These innovations are continually transformed into new drivers of growth. At this year's CIIE, Fosun introduced several latest products that are leading industry transformation. In the field of neurological disease treatment, especially for conditions like essential tremor and Parkinson's disease, patients have long faced challenges with unmet clinical needs. Traditional drug and surgical treatments often have limitations, but advancements in non-invasive treatment technologies have brought new hope to these patients. Fosun has actively responded to this unmet clinical need. At this year's CIIE, the new V2 model of the CNS (Central Nervous System) innovative treatment technology, the V2 model of "Exablate Neuro FUS system" made its debut in China, generating high expectations within the industry. This new model has already received CE certification in Europe and FDA approval in the United States and submitted a registration application to China's National Medical Products Administration in 2024. The V2 model's innovation lies in providing a non-invasive surgical solution for clinically drug-resistant essential tremor and tremor-dominant Parkinson's disease, while also being compatible with a broader range of MRI models, further enhancing the accessibility of this technology. Last year, Fosun, in partnership with Insightec, showcased the "Exablate Neuro" at CIIE, drawing much attention and continuous interest in collaboration. Leveraging the CIIE's "spillover effect", Fosun Pharma and Insightec established a joint venture, Fosun-Insightec, in February this year. The venture is focused on the marketing and developing clinical efforts of Exablate Neuro FUS system in improving the lives of patient living with essential tremor and Parkinson's disease, working to help them regain their quality life and wellbeing. Focusing on innovating to meet real customer needs is a core methodology for Fosun. Data shows that Fosun has made long-term investments in technological innovation, with an investment of RMB 3.5 billion in the first half of this year. Connecting Globally to Enhance Accessibility of Innovative Drugs, Benefiting more Patients Leveraging the CIIE's openness, Fosun also presented innovative products focused on solid tumors, hematological tumors, and immune-inflammatory conditions. Fosun's seven-year journey at CIIE has facilitated the introductions of global products and enabled the export of local innovations to benefit more patients worldwide. In 2017, Fosun introduced China's first CAR-T cell therapy product, Yi Kai Da (ejilunsai injection). Since then, by continuously participating in the CIIE, Fosun has enabled the public to gain an in-depth understanding of this advanced therapy. At this year's CIIE, Fosun highlighted Yi Kai Da's latest developments in the "accessibility and treatability" in lymphoma treatment. Yi Kai Da is now included in over 110 urban customized commercial health insurances and more than 80 commercial insurances, created a new path of payment mode for patients; and over 170 high-standard treatment centers across 28 regions in China providing treatments for over 900 lymphoma patients, achieving revolutionary innovative breakthroughs for cancer care. As a global company rooted in China, Fosun has an extensive industrial presence in over 35 countries and regions worldwide, with robust global R&D capabilities and impressive progress. This year, Fosun also showcased several innovative products, including the world's first and only dual-channel fixed-dose combination oral formulation, Akynzeo® oral (Netupitant and Palonosetron hydrochloride), which blocks both NK-1 and 5-HT3 receptors; the immunoglobulin Thymoglobulin® for improving transplant patient outcomes; the world's first oral targeted medication for psoriasis, Otezla® (apremilast tablets); a new third-generation COMT inhibitor Ongentys® (Opicapone) for managing symptom fluctuations in adult Parkinson's disease patients; and Parsabiv® (Etelcalcetide Hydrochloride Injection), the only peptide-based calcimimetic for treating secondary hyperparathyroidism in adult dialysis patients with chronic kidney disease. Guo Guangchang concluded, "Participating in CIIE has been a top priority for Fosun for seven consecutive years. We have witnessed CIIE become a crucial platform for global companies to share in China's development opportunities and deepened our global partnerships through this platform. We believe the CIIE stage will continue to expand, and Fosun's journey of innovation and globalization will grow broader." SOURCE Fosun WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapy

24 Jun 2024

·www.globenewswire.com

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US

Helsinn Group announces AKYNZEO® (fosnetupitant/palonosetron) injection is now available in a ready-to-use vial in the US Lugano, Switzerland – June 24, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, is pleased to announce that AKYNZEO® (fosnetupitant/palonosetron) injection is now available in the US in a ready-to-use vial. AKYNZEO injection (Ready-to-Use) is a new method of administration and contains the same formulation as the prior AKYNZEO Injection (To-be-Diluted). The features of the new ready-to-use presentation of AKYNZEO injection include: No reconstitution or dilution required; infuse directly from the vial using a built-in hanging strapNo refrigeration required at any point during distribution, storage, or preparationAccessible via automated dispensing machine, allowing the product to be stored and available near the location of patient care AKYNZEO injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. It has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO injection does not contain polysorbate 80 or allergenic excipients such as soy or egg lecithin. It can be administered simultaneously with intravenous dexamethasone sodium phosphate. Dr. Melanie Rolli, Helsinn Group CEO, commented: “As a pioneer in cancer supportive care, Helsinn continues to be unwavering in our pursuit to help patients and clinicians in cancer care. We are very pleased to launch the new AKYNZEO Ready-to-Use vial, building on our legacy of innovation.” Ordering information Clinicians wishing to order the new vial should contact their GPO or distributor. The National Drug Code (NDC) number for AKYNZEO injection vial with hanger (Ready-to-Use) is 69639-106-01 and the J Code is J1454 (Injection, fosnetupitant 235 mg and palonosetron 0.25 mg); billing unit (single dose vial [SDV]). About AKYNZEO® AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and fosnetupitant, a substance P/neurokinin-1 (NK-1) receptor antagonist: palonosetron prevents nausea and vomiting during the acute phase and fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT3 receptor antagonists.Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs. Adverse Reactions Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules. Drug Interactions Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days Dexamethasone doses should be reduced when given with AKYNZEO. A more than two- fold increase in the systemic exposure of dexamethasone was observed 4 days after a single infusion of fosnetupitant.Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased. Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO. Use in Specific Populations Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease.Advise women of potential risk to fetus; limited data are available; may cause fetal harm. For more information about AKYNZEO® please see the full US Prescribing Information. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com

Drug ApprovalClinical Result

12 Jun 2024

·www.globenewswire.com

Helsinn Group and Chugai Pharma Europe sign a partnership agreement renewal to commercialize AKYNZEO® in the UK and Ireland

Helsinn Group and Chugai Pharma Europe sign a partnership agreement renewal to commercialize AKYNZEO® in the UK and Ireland Lugano, Switzerland – June 12, 2024 – Helsinn Group (“Helsinn”), a global pharmaceutical company with a track record of over forty-five years of commercial execution and a strong focus in supportive care, oncology and dermato-oncology, and Chugai Pharma Europe Ltd (“Chugai”), the European subsidiary of Chugai Pharmaceutical Co, Ltd., one of Japan’s leading research-based pharmaceutical companies, today announced the signing of the Distribution and Licence Agreement renewal in the United Kingdom of Great Britain and Northern Ireland, and the Republic of Ireland, for AKYNZEO® (combination of netupitant-palonosetron), for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients. Troy Robinson, Managing Director at Chugai Pharma Europe, commented: “We are delighted to have signed this agreement with Helsinn and are proud to continue this collaboration. Oncology remains an important pillar of our Chugai business, and this agreement reflects our ongoing commitment to improving the quality of cancer care. Our joint efforts with Helsinn will ensure that we continue to support patients in the UK and Ireland throughout their cancer journey, providing access to AKYNZEO®, a valuable supportive care product.” Dr. Melanie Rolli, Helsinn Group CEO, commented: “This renewed partnership agreement with Chugai marks a significant milestone. Chugai has been an excellent partner for Helsinn over the past ten years. Our shared vision, values and unwavering dedication to supportive care will continue to fuel our collective journey in enhancing the quality of life for cancer patients in this crucial market. We look forward to exciting new opportunities that lie ahead with Chugai as we build upon our already robust and enduring foundation.” About AKYNZEO® AKYNZEO® is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved in adults for the prevention of acute and delayed nausea and vomiting associated with highly and moderately emetogenic chemotherapy. For additional information please see the EU Summary of Product Characteristics. About Chugai Pharma Europe Chugai Pharma Europe (CPE) is a regional business and wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd., one of Japan’s leading research-based pharmaceutical companies and a member of the Roche Group. Established in 1993, CPE coordinates Chugai’s commercial, medical, and business activities in Europe, with a focus on oncology, rheumatology, and haematology. Headquartered in London, CPE also supports clinical research programmes for Japan, and explores co-development and in-licensing opportunities with an established network of partners. United by our purpose to shape a brighter, healthier future in Europe, our people are passionate about adding value to the medical community and human health. Supporting CPE to deliver advanced and sustainable patient-centric healthcare, and embody our core values to prioritize patient wellbeing, pursue innovation, and maintain the highest ethical and moral standards in everything we do. For more information, please visit https://www.chugai.eu/ or follow us on LinkedIn and x. About Helsinn Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries. Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision. To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X. For more information: Helsinn Group Media Contact:Sabrina PerucchiGroup Communication ManagerLugano, Switzerland Tel: +41 (0) 91 985 21 21 Email: Info-hhc@helsinn.com Chugai Pharma Europe: Robert MackichanSenior PR & Communications Manager, EuropeLondon, UKTel: +44 (0) 20 8987 5600Email: r.mackichan@chugai-pharm.co.uk

License out/inDrug Approval

100 Deals associated with Netupitant/Palonosetron Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
-	Netupitant/Palonosetron Hydrochloride	A04AA	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Nausea	CA	Knight Therapeutics, Inc.	20 Nov 2017
Vomiting	CA	Knight Therapeutics, Inc.	20 Nov 2017
Chemotherapy-induced nausea and vomiting	US	Helsinn Healthcare SA	10 Oct 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Vomiting	NDA/BLA	KR	HK inno.N Corp.	-
Chemotherapy-induced nausea and vomiting	Preclinical	PL	Helsinn Healthcare SA	01 Apr 2011
Chemotherapy-induced nausea and vomiting	Discovery	BG	Helsinn Healthcare SA	01 Apr 2011
Chemotherapy-induced nausea and vomiting	Discovery	RU	Helsinn Healthcare SA	01 Apr 2011
Chemotherapy-induced nausea and vomiting	Discovery	MX	Helsinn Healthcare SA	01 Apr 2011
Chemotherapy-induced nausea and vomiting	Discovery	RO	Helsinn Healthcare SA	01 Apr 2011
Chemotherapy-induced nausea and vomiting	Discovery	HU	Helsinn Healthcare SA	01 Apr 2011
Chemotherapy-induced nausea and vomiting	Discovery	BR	Helsinn Healthcare SA	01 Apr 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CTRI/2023/04/051951 (ASCO2024) Manual	Phase 4	Chemotherapy-induced nausea and vomiting	178	IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) (HEC)	(nyqckxldeb) = sfivabyhlk tqjwnmnldx (judvxayzgx ) View more	Positive	24 May 2024
				IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) (MEC)	(nyqckxldeb) = mplqvgtcxa tqjwnmnldx (judvxayzgx ) View more
NCT03040726 (CTgov)	Phase 2/3	Nausea \| Neoplasms \| Vomiting	53	Palonosetron (NEPA)+Netupitant (Blinded Intervention Group)	bupcvlgkjj(lgegmmicyr) = pmnzsbwqnh bohkxtycep (rmyggcmgvc, susdubsyzm - skbmnsgshz) View more	-	17 Oct 2023
				Placebo (Blinded Placebo Group)	bupcvlgkjj(lgegmmicyr) = vfbljxcezp bohkxtycep (rmyggcmgvc, xkhbkchppj - sbjzjsevsa) View more
EHA2023	Not Applicable	Hematopoietic stem cell transplantation \| Lymphoma	76	NEPA	prnjfnzvaz(dlfjoonalm) = frglejascy lxokgqjopx (bqmfrjnuhn ) View more	-	08 Jun 2023
				Ondansetron	prnjfnzvaz(dlfjoonalm) = tduaakxbwb lxokgqjopx (bqmfrjnuhn ) View more
NCT04201769 (Pubmed)	Phase 3	Chemotherapy-induced nausea and vomiting \| Non-Small Cell Lung Cancer \| Vomiting	228	NEPA plus no further DEX	(gwullryjuu) = ynrzucfsxb ntbblticer (nmpdodrrrf, 59.7 - 86.8) View more	Positive	06 Jun 2023
				NEPA plus oral low-dose DEX (4 mg) on days 2-3	(gwullryjuu) = mmcthmcvvt ntbblticer (nmpdodrrrf, 62.5 - 92.6) View more
P543 (EBMT2023)	Not Applicable	-	70	NEPA and low dose of dexamethasone	(pjsazyshfp) = one patient experienced grade 1 abdominal pain zmlgyofkmd (dktwyczhml ) View more	-	23 Apr 2023
ASCO2022 Manual	Not Applicable	Chemotherapy-induced nausea and vomiting	289	Netupitant/Palonosetron Hydrochloride (HEC regimens)	(usqahehpxg) = adwznomaac cadiisrkna (hysqqydfbi ) View more	Positive	02 Jun 2022
NCT03097588 (CTgov)	Phase 2	Nausea \| Chemotherapy-induced nausea and vomiting \| Neoplasms \| Vomiting	43	Questionnaire Administration+Palonosetron Hydrochloride+Netupitant	drlmzoyvlz(mvzniypaud) = womursfxen eoqcplfnzd (kyjwramqez, bzjpredxoy - eigknpyaca) View more	-	03 Jun 2021
NCT03204279 (CINV, CTgov)	Phase 2	Nausea \| Chemotherapy-induced nausea and vomiting \| Neoplasms \| Vomiting	67	Palonosetron+Netupitant (Netupitant 1.33 mg/kg Plus Palonosetron)	ecjfjnmpjy(dolgwxoqmt) = qwhggaqnhx scfzjxfbpp (vroflztsqm, tqvzdchhkc - mnwnwmnehv) View more	-	07 Dec 2020
				Palonosetron+Netupitant (Netupitant 4 mg/kg Plus Palonosetron)	xkysbucxbg(oyvjfyuawf) = qcbdoevhmb ucckyorasf (rbdlwblhvv, hinfsmrdsg - injnrgvdvb) View more
NCT03079219 \| NCT03386617 (ESMO_ASIA_VIRTUAL2020)	Not Applicable	Breast Cancer	120	Olanzapine-based regimen	(elryxmalyh) = dtulvpatno nxhuspqafd (unwspixfir ) View more	-	22 Nov 2020
				NEPA-based regimen	(elryxmalyh) = pyyvefulja nxhuspqafd (unwspixfir ) View more
AkyPRO (ESMO2020)	Not Applicable	-	-	NEPA	byosfatlaq(qpglbmwzdl) = cbhwboefcq rhftfwmfpy (icdtduhbqf ) View more	-	17 Sep 2020

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