PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors), PARP3 inhibitors(Poly (ADP-Ribose) Polymerase 3 inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [3]

Active Indication

Fallopian Tube CarcinomaOvarian Epithelial CarcinomaPrimary peritoneal carcinoma+ [19]

Inactive Indication

Advanced Cervical CarcinomaAdvanced Malignant Solid NeoplasmBRCA-Mutated Malignant Neoplasm+ [20]

Originator Organization

Pfizer Inc.

Active Organization

Pharma& Schweiz GmbH

Foundation Medicine, Inc.

Bristol Myers Squibb Co.

+ [6]

Inactive Organization

Hoffmann-La Roche, Inc.

Pfizer Inc.North Eastern German Society of Gynaecological Oncology

Drug Highest PhaseApproved

First Approval Date

US (19 Dec 2016),

BRCA-mutated Ovarian Cancer

RegulationBreakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US)

Structure

Molecular FormulaC29H34FN3O5S

InChIKeyINBJJAFXHQQSRW-STOWLHSFSA-N

CAS Registry1859053-21-6

Clinical Trials associated with Rucaparib Camsylate

CTRI/2022/02/040221 / RecruitingPhase 2IIT

177Lu-PSMA-617 plus low-dose rucaparib in metastatic castration-resistant prostate cancer: A randomized, controlled phase 2 trial (LuPlus) - LuPlus

Start Date01 Apr 2022

Sponsor / Collaborator-

EUCTR2020-001538-37-ES / Unknown statusPhase 3

CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy with Rucaparib - CATCH - R

Start Date28 Jun 2021

Sponsor / Collaborator

Clovis Oncology, Inc.

NCT04676334 / CompletedPhase 3

CATCH-R: A Rollover Study to Provide Continued Access to Clinical Therapy With Rucaparib

This protocol is designed to provide participants currently benefiting from rucaparib treatment in a Clovis-sponsored clinical study with continued access to treatment for as long as they continue to benefit. Participants in long-term follow-up (LTFU) in a parent study may also enroll in this study for continued data collection, as applicable based on parent study objectives.

Start Date22 Mar 2021

Sponsor / Collaborator-

100 Clinical Results associated with Rucaparib Camsylate

100 Translational Medicine associated with Rucaparib Camsylate

100 Patents (Medical) associated with Rucaparib Camsylate

539

Literatures (Medical) associated with Rucaparib Camsylate

31 Dec 2024·Journal of Pharmaceutical Policy and Practice

Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway

Article

Author: Shahzad, Mahnum ; Esselen, Katharine M ; Naci, Huseyin ; Wagner, Anita K ; Dottino, Joseph A

Background:

Withdrawals of drug indications may reveal potential inadequacies in the regulatory approval processes of new drugs. Understanding potential weaknesses of the regulatory approval process is paramount given the increasing use of expedited pathways. In this paper, we focus on three poly-ADP-ribose polymerase inhibitors (olaparib, rucaparib and niraparib) for the treatment of women with heavily pretreated, recurrent ovarian cancer, which were eventually withdrawn.

Methods:

We use a comparative case study approach to evaluate the regulatory histories of these drug indications in the US and Europe.

Results:

Two drug indications benefited from the FDA's accelerated approval pathway, which explicitly lowers the bar for evidence of efficacy at the time of approval. Following accelerated approval, manufacturers are mandated to conduct post-marketing studies to confirm clinical benefit. The FDA granted accelerated approval to olaparib and rucaparib based on data on surrogate endpoints and converted the approval to regular approval after the submission of additional data on surrogate endpoints from one of two required confirmatory trials, that is, without data on clinical benefit. Niraparib directly received regular approval based only on data on a surrogate endpoint. By contrast, the EMA granted conditional marketing authorisation to rucaparib and was quicker to restrict usage than the FDA.

Conclusion:

The regulatory histories of these drug indications highlight the need to reform the accelerated approval pathway by ensuring that post-marketing requirements are followed, and that regular approval is only based on evidence of clinical benefit.

01 Nov 2024·RADIOTHERAPY AND ONCOLOGY

Talazoparib enhances resection at DSBs and renders HR-proficient cancer cells susceptible to Polθ inhibition

Article

Author: Mladenov, Emil ; Sun, Yanjie ; Hessenow, Razan ; Guberina, Maja ; Iliakis, George ; Stuschke, Martin ; Lin, Xixi ; Soni, Aashish

BACKGROUND AND PURPOSE:

The PARP inhibitor (PARPi), Talazoparib (BMN673), effectively and specifically radiosensitizes cancer cells. Radiosensitization is mediated by a shift in the repair of ionizing radiation (IR)-induced DNA double-strand breaks (DSBs) toward PARP1-independent, alternative end-joining (alt-EJ). DNA polymerase theta (Polθ) is a key component of this PARP1-independent alt-EJ pathway and we show here that its inhibition can further radiosensitize talazoparib-treated cells. The purpose of the present work is to explore mechanisms and dynamics underpinning enhanced talazoparib radiosensitization by Polθ inhibitors in HR-proficient cancer cells.

METHODS AND MATERIALS:

Radiosensitization to PARPis, talazoparib, olaparib, rucaparib and veliparib was assessed by clonogenic survival. Polθ-proficient and -deficient cells were treated with PARPis and/or with the Polθ inhibitors ART558 or novobiocin. The role of DNA end-resection was studied by down-regulating CtIP and MRE11 expression using siRNAs. DSB repair was assessed by scoring γH2AX foci. The formation of chromosomal abnormalities was assessed as evidence of alt-EJ function using G₂-specific cytogenetic analysis.

RESULTS:

Talazoparib exerted pronounced radiosensitization that varied among the tested cancer cell lines; however, radiosensitization was undetectable in normal cells. Other commonly used PARPis, olaparib, veliparib, or rucaparib were ineffective radiosensitizers under our experimental conditions. Although genetic ablation or pharmacological inhibition of Polθ only mildly radiosensitized cancer cells, talazoparib-treated cells were markedly further radiosensitized. Mechanistically, talazoparib shunted DSBs to Polθ-dependent alt-EJ by enhancing DNA end-resection in a CtIP- and MRE11-dependent manner - an effect detectable at low, but not high IR doses. Chromosomal translocation analysis in talazoparib-treated cells exposed to Polθ inhibitors suggested that PARP1- and Polθ-dependent alt-EJ pathways may complement, but also back up each other.

CONCLUSION:

We propose that talazoparib promotes low-dose, CtIP/MRE11-dependent resection and increases the reliance of irradiated HR-proficient cancer cells, on Polθ-mediated alt-EJ. The combination of Polθ inhibitors with talazoparib suppresses this option and causes further radiosensitization. The results suggest that Polθ inhibition may be exploited to maximize talazoparib radiosensitization of HR-proficient tumors in the clinic.

21 Sep 2024·BRITISH JOURNAL OF CANCER

ATR, CHK1 and WEE1 inhibitors cause homologous recombination repair deficiency to induce synthetic lethality with PARP inhibitors

Article

Author: Prendergast, Lisa ; Curtin, Nicola J ; Willmore, Elaine ; Smith, Hannah L

Abstract:

Purpose:

PARP inhibitors (PARPi) are effective in homologous recombination repair (HRR) defective (HRD) cancers. To (re)sensitise HRR proficient (HRP) tumours to PARPi combinations with other drugs are being explored. Our aim was to determine the mechanism underpinning the sensitisation to PARPi by inhibitors of cell cycle checkpoint kinases ATR, CHK1 and WEE1.

Experimental design:

A panel of HRD and HRP cells (including matched BRCA1 or 2 mutant and corrected pairs) and ovarian cancer ascites cells were used. Rucaparib (PARPi) induced replication stress (RS) and HRR (immunofluorescence microscopy for γH2AX and RAD51 foci, respectively), cell cycle changes (flow cytometry), activation of ATR, CHK1 and WEE1 (Western Blot for pCHK1S345, pCHK1S296 and pCDK1Y15, respectively) and cytotoxicity (colony formation assay) was determined, followed by investigations of the impact on all of these parameters by inhibitors of ATR (VE-821, 1 µM), CHK1 (PF-477736, 50 nM) and WEE1 (MK-1775, 100 nM).

Results:

Rucaparib induced RS (3 to10-fold), S-phase accumulation (2-fold) and ATR, CHK1 and WEE1 activation (up to 3-fold), and VE-821, PF-477736 and MK-1775 inhibited their targets and abrogated these rucaparib-induced cell cycle changes in HRP and HRD cells. Rucaparib activated HRR in HRP cells only and was (60-1,000x) more cytotoxic to HRD cells. VE-821, PF-477736 and MK-1775 blocked HRR and sensitised HRP but not HRD cells and primary ovarian ascites to rucaparib.

Conclusions:

Our data indicate that, rather than acting via abrogation of cell cycle checkpoints, ATR, CHK1 and WEE1 inhibitors cause an HRD phenotype and hence “induced synthetic lethality” with PARPi.

News (Medical) associated with Rucaparib Camsylate

14 Sep 2024

·www.fiercepharma.com

ESMO: GSK's Zejula misses survival goal in first-line ovarian cancer, as pharma&'s combo disappoints

The PARP inhibitor class, featuring drugs from GSK, AstraZeneca/Merck and pharma&, has faced serious regulatory setbacks before this pair of clinical disappointments. In a rough day for PARP inhibitors in ovarian cancer, GSK’s Zejula didn’t deliver a life extension benefit in the final analysis of a phase 3 trial. Another study showed that pharma&’s attempt to enhance its Rubraca with Bristol Myers Squibb’s Opdivo seriously backfired.GSK’s Zejula boasts a broad U.S. approval as a first-line maintenance treatment for ovarian cancer patients who have responded to initial platinum-based chemotherapy. But the phase 3 study that earned the drug that approval, PRIMA, has now shown at its final analysis that Zejula didn’t extend patients’ lives compared with placebo.After a median follow-up of about 74 months, patients in the PRIMA trial who took Zejula as a first-line maintenance treatment were essentially as likely to die as those who received placebo. In fact, Zejula was linked to a 1% higher risk of death, as Zejula takers lived a median 46.6 months, versus 48.8 months for control, according to results presented at the European Society for Medical Oncology (ESMO) 2024 annual meeting.The negative overall survival showing, however marginal, raises the possibility of an FDA crackdown like the one the agency waged on the PARP inhibitor class about two years ago. At that time, several later-line ovarian cancer indications for Zejula, AstraZeneca and Merck’s Lynparza, and the then-Clovis Oncology-owned Rubraca were withdrawn or restricted after the FDA noted a potential long-term detriment to patient survival. Zejula’s OS readoutThe risk of death in PRIMA only turned against Zejula after a small group of patients with undetermined status on the homologous-recombination biomarker were counted, GSK’s global head of oncology R&D, Hesham Abdullah, M.D., noted in an interview with Fierce Pharma. Zejula was associated with a positive 5% reduction in the risk of death in patients with homologous recombination-deficient (HRd) tumors and a 7% improvement in the homologous recombination-proficient (HRp) population. None of the above numbers carry statistical significance.Zejula secured its FDA approval for the first-line maintenance treatment of ovarian cancer—regardless of biomarker status—in 2020 after the PRIMA trial demonstrated that the drug could reduce the risk of disease progression or death by 38% versus placebo. At the time, the biggest benefit was seen in those with BRCA mutations, followed by other HRd types, then HRp tumors, with those with undetermined biomarker status experiencing the least benefit.More therapies have emerged for ovarian cancer since the PRIMA trial, and the overall survival analysis was likely confounded by the use of subsequent therapies, Abdullah said. About 38% of patients in the placebo arm received subsequent PARP inhibitor treatment in PRIMA, versus 12% for the Zejula arm. In the HRd subgroup, the difference was even bigger, with the rates at 48% and 16%, respectively. Still, at first glance, Zejula’s overall survival performance in PRIMA appears weaker than the result from its rival Lynparza in the PAOLA-1 trial, with cross-trial caveats considered. In a descriptive analysis of overall survival in HRd-positive patients, Lynparza plus bevacizumab reduced the risk of death by 38% versus bevacizumab alone in the PAOLA-1 trial.Lynparza’s FDA approval in first-line maintenance ovarian cancer is limited to HRd patients, and the AZ/Merck drug remains the PARP class leader within its approved HRd population. As doctors are more reluctant to use PARP inhibitors in HRp patients, Zejula’s sales have been lagging far behind Lynparza’s quarterly figures.PRIMA enrolled a higher-risk patient population compared with other studies, Abdullah said, pointing to such factors as stage of disease, visible residual disease and prior use of neoadjuvant chemotherapy as evidence.GSK will communicate the latest PRIMA data with the FDA, but Abdullah declined to comment further about potential regulatory actions.Zejula continued to show a benefit in slowing disease progression or death. At five years, about 22% of patients in the Zejula arm were estimated to be alive, versus 12% for placebo. The rates in the HRd population were 35% and 16%, respectively.“We’re comforted by the long-term safety profile and data that we see through survival despite the impact of subsequent therapies,” Abdullah said. Rubraca’s combo setbackAmong the three PARP inhibitors that have an ovarian cancer indication, pharma&’s Rubraca is the smallest player by market share. The Austrian company took over the struggling drug from the bankrupt Clovis Oncology last year. Before that, Clovis had tried to plump up Rubraca’s profile by combining the drug with BMS’ PD-1 inhibitor Opdivo. That now appears to have been a bad idea.Pharma& unveiled the failure of the Rubraca-Opdivo combo as a first-line maintenance treatment for ovarian cancer in May. Now, data from the phase 3 ATHENA-COMBO trial presented at ESMO 2024 show that patients who got the cocktail performed even worse than those who received Rubraca alone.The ATHENA-COMBO trial was a complete failure no matter which patient group was examined. In the overall trial group, the combo showed a 30% increased risk of disease progression or death versus solo Rubraca, as the median PFS was 15 months for the combo and 20.2 months for Rubraca monotherapy.In patients with or without BRCA mutations, with various levels of heterozygosity, or those with PD-L1-positive tumors, the results were the same: The Rubrca-Opdivo regimen was worse.In terms of treatment-related adverse events at grade 3 or higher, the combo arm saw a higher rate of elevated liver enzymes, which suggest liver dysfunction, at 21.2%, compared with 10% for the monotherapy arm. Patients in the combo arm stayed notably shorter on their treatment, as the median exposure to Rubraca was 8.4 months among them, compared with 14.7 months in the control group.How thoroughly the ATHENA-COMBO trial failed was somewhat of a surprise. The phase 3 DUO-O trial previously showed positive tumor progression results for adding AZ’s PD-L1 inhibitor Imfinzi to first-line chemo and bevacizumab and then adding Imfinzi and Lynparza to bevacizumab in the maintenance phase. However, that study didn’t establish a clear contribution from Imfinzi, and AZ doesn't seem to have made any regulatory filing for that use.“While the negative primary results were disappointing, the findings provide further support of Rubraca monotherapy” in the first-line maintenance setting, a pharma& spokesperson said about ATHENA-COMBO in a statement to Fierce Pharma.The problem is, Rubraca as a monotherapy has yet to win an FDA approval as a first-line maintenance treatment in ovarian cancer. Amid the FDA’s previous crackdown on the PARP inhibitor class, the agency last year rejected Rubraca’s application in that first-line setting, requesting long-term overall survival analysis from the phase 3 ATHENA-MONO trial. Likely as a punishment for Clovis’ rogue decision to file the application despite the agency’s prior warning, the FDA actually elevated its request in the rejection, asking for the final overall survival analysis in any potential future refiling. The final analysis from ATHENA-MONO will happen when 70% of patients in the trial have passed away, whereas the agency had previously told Clovis that a 50% maturity threshold would have been enough.Pharma& spoke with the FDA again in May this year, and the agency maintained its stance stated in the complete response letter, the pharma& spokesperson told Fierce. As such, the company will continue the ATHENA-MONO trial and explore a future FDA regulatory path, the spokesperson added.Even as the FDA wards off Rubraca’s first-line bid, the European Commission in November approved that indication. This month, the drug just won reimbursement in France for that first-line maintenance use, the company spokesperson said.

Phase 3Clinical ResultDrug Approval

13 Sep 2024

·www.globenewswire.com

Nxera’s Partner Cancer Research UK to Present on Phase 1/2a Clinical Trial with Cancer Immunotherapy Drug HTL0039732 at ESMO

HTL0039732 (also known as NXE0039732) is Nxera’s novel oral EP4 antagonist with the potential to treat a wide range of cancers in combination with other immunotherapies Cancer Research UK’s Centre for Drug Development is sponsoring and managing the ongoing Phase 1/2a clinical trial of HTL0039732 13 September 2024 – Nxera Pharma (TSE: 4565, “Nxera”) and Cancer Research UK announce an upcoming presentation on the ongoing Phase 1/2a clinical trial (NCT05944237) of Nxera’s immunotherapy drug HTL0039732 (also known as NXE0039732) at the European Society for Medical Oncology Congress (ESMO) 2024, taking place on 13–17 September in Barcelona, Spain. The trial’s co-chief investigator, Dr. Debashis Sarker from Guy's and St Thomas’ NHS Foundation Trust, will present a “Trial in Progress1” poster at ESMO 2024 on Saturday 14 September (presentation 679TiP, available on the ESMO website here). The first-in-human trial is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of HTL0039732 as a monotherapy and in combination with the checkpoint inhibitor atezolizumab, in patients with advanced solid tumors. HTL0039732 is an oral small molecule drug candidate that was rationally designed using Nxera’s NxWave™ platform and evaluated through rigorous translational and preclinical studies. HTL0039732 works by blocking signaling through a specific type of prostaglandin receptor, the prostaglandin E2 (PGE2)-type prostanoid receptor 4 (EP4). PGE2 acts in the tumor microenvironment to trigger cancer cells to evade the immune system. Targeting EP4 to block the effects of PGE2 increases the ability of the immune system to detect and control cancer cells and makes HTL0039732 a potential candidate to treat patients with cancers that generally do not respond well to current immunotherapies. Cancer Research UK’s Centre for Drug Development is sponsoring and managing the trial, which is led by chief investigator Dr Bristi Basu, University of Cambridge, and Dr Sarker. The first patient was dosed in August 2023 and the trial is currently open for recruitment at Addenbrooke’s Hospital in Cambridge, Guy’s Hospital in London, and the Christie Hospital in Manchester. Dr. Debashis Sarker says: “We are excited to present this ‘Trials in Progress’ poster at ESMO, outlining the scientific rationale and design of the clinical trial of HTL0039732, given alone and in combination with immunotherapy for patients with advanced solid cancers. HTL0039732 targets an important protein within the tumor immune microenvironment called EP4, triggering cancer cells to evade the immune system. Targeting EP4 potentially increases the ability of the immune system to detect and control cancer cells. Enrolment to the trial began in the UK in August 2023 and is ongoing across multiple cancer types. “We are hopeful that this trial will identify a novel way to target the immune system and improve treatment options for patients with a range of different solid cancers.” Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. In addition to several products being commercialized in Japan, we are advancing an extensive pipeline of over 30 active programs from discovery through to late clinical stage internally and in partnership with leading pharma and biotech companies. This pipeline is focused on addressing major unmet needs in some of the fastest-growing areas of medicine across neurology, GI and immunology, metabolic disorders and rare diseases, and leverages the power of our unique and industry leading GPCR-targeted structure-based drug discovery “NxWaveTM” platform to provide a sustainable source of best- or first-in-class candidates. Nxera employs over 350 talented people at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565). Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market. It currently has a portfolio of 16 projects in preclinical development, Phase 1 or early Phase 2 clinical trials. www.cruk.org.uk/cdd 1 A “Trial in Progress” presentation describes the rationale behind and design of a clinical trial. No data will be presented. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyPhase 3

12 Sep 2024

·www.prnewswire.com

Florida Cancer Specialists & Research Institute Contributing to Transformative Cancer Therapies Worldwide

Research Findings Featured at European Medical Oncology Congress FORT MYERS, Fla., Sept. 12, 2024 /PRNewswire/ -- Cutting-edge clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) is being shared this week at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. Six FCS physicians are first authors and/or co-authors of 20 cancer research studies that will be featured when oncology professionals from around the globe convene to review and discuss significant scientific discoveries that are driving optimal outcomes for cancer patients everywhere. Continue Reading Six Florida Cancer Specialists & Research Institute physicians are first authors and/or co-authors of 20 cancer research studies that will be featured at the European Society of Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain. (PRNewsfoto/Florida Cancer Specialists & Research Institute) Lucio N. Gordan, MD, FCS president and managing physician, said, "With more Phase 1 clinical trial patients than most academic centers across the country and a rapidly expanding late-phase clinical trials program, FCS is engaged in significant and transformative scientific discoveries that are advancing oncology practice and contributing to better patient outcomes." The following physician leaders of the FCS clinical research program are first authors of two abstracts that will be featured in oral presentations during the meeting: Bradley Monk, MD, FCS medical director of late-phase clinical research, a Phase 3, randomized trial comparing rucaparib (RUCA) + nivolumab (NIVO) combination therapy vs RUCA monotherapy as maintenance treatment in patients with newly diagnosed ovarian cancer. Manish Patel, MD, FCS director of drug development, a Phase 1, first-in-human study of DS-9606a, a claudin 6 (CLDN6)-directed antibody-drug conjugate (ADC), in patients with tumor types known to express CLDN6. "My colleagues and I welcome this opportunity to engage in a first-hand exchange of data and expert discussion of how we can best apply these findings into clinical care and into the design of the next generation of clinical trials," said Dr. Patel. Research that the following FCS principal investigators have co-authored will also be presented in various sessions, 20 in total, highlighting a variety of cancer types and treatment modalities: Amir Harandi, MD, MS (1) Bradley Monk, MD (5) Manish Patel, MD (8) Ivor Percent, MD (1) Cesar Augusto Perez, MD (1) Judy Wang, MD (4) FCS offers more opportunities to enroll in clinical trials than any other community-based oncology provider in Florida. At any given time, FCS conducts more than 180 early and late-phase clinical trials in its 30 late-phase research locations and three drug development units in Florida, serving over 600 patients annually. A longstanding partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials, provides patients with access to a comprehensive listing of clinical trials available in the U.S. Additionally, FCS recently announced a partnership with Paradigm Health, Inc., to help streamline and accelerate matching patients to available clinical trials. With more than 35,000 members comprised of oncology professionals from 172 countries, ESMO is the leading professional organization for medical oncology. The ESMO Congress 2024 is a globally influential oncology platform for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. All of the study abstracts will be published online in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology. About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with FCS participation.* Recognized for our research, FCS is a recipient of the national Clinical Trials Participation Award presented by the American Society of Clinical Oncology (ASCO). FCS physicians, trained in prestigious medical schools and research institutes, are consistently ranked nationally as Top Doctors by U.S. News & World Report. Celebrating its 40th year in 2024, FCS has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies genomic-based treatment and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff. *Prior to approval SOURCE Florida Cancer Specialists & Research Institute WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOPhase 1Phase 3

100 Deals associated with Rucaparib Camsylate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Rucaparib Camsylate	L01XX	DB12332

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Fallopian Tube Carcinoma	EU	Pharma& Schweiz GmbH	30 Nov 2023
Fallopian Tube Carcinoma	IS	Pharma& Schweiz GmbH	30 Nov 2023
Fallopian Tube Carcinoma	LI	Pharma& Schweiz GmbH	30 Nov 2023
Fallopian Tube Carcinoma	NO	Pharma& Schweiz GmbH	30 Nov 2023
Ovarian Epithelial Carcinoma	EU	Pharma& Schweiz GmbH	30 Nov 2023
Ovarian Epithelial Carcinoma	IS	Pharma& Schweiz GmbH	30 Nov 2023
Ovarian Epithelial Carcinoma	LI	Pharma& Schweiz GmbH	30 Nov 2023
Ovarian Epithelial Carcinoma	NO	Pharma& Schweiz GmbH	30 Nov 2023
Primary peritoneal carcinoma	EU	Pharma& Schweiz GmbH	30 Nov 2023
Primary peritoneal carcinoma	IS	Pharma& Schweiz GmbH	30 Nov 2023
Primary peritoneal carcinoma	LI	Pharma& Schweiz GmbH	30 Nov 2023
Primary peritoneal carcinoma	NO	Pharma& Schweiz GmbH	30 Nov 2023
BRCA Mutation Castration-Resistant Prostate Cancer	US	zr pharma& GmbH	15 May 2020
Platinum-sensitive epithelial ovarian cancer	EU	Pharma& Schweiz GmbH	23 May 2018
Platinum-sensitive epithelial ovarian cancer	IS	Pharma& Schweiz GmbH	23 May 2018
Platinum-sensitive epithelial ovarian cancer	LI	Pharma& Schweiz GmbH	23 May 2018
Platinum-sensitive epithelial ovarian cancer	NO	Pharma& Schweiz GmbH	23 May 2018
Platinum-Sensitive Fallopian Tube Carcinoma	EU	Pharma& Schweiz GmbH	23 May 2018
Platinum-Sensitive Fallopian Tube Carcinoma	IS	Pharma& Schweiz GmbH	23 May 2018
Platinum-Sensitive Fallopian Tube Carcinoma	LI	Pharma& Schweiz GmbH	23 May 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Platinum-Sensitive Ovarian Carcinoma	Phase 3	US	Bristol Myers Squibb Co.	30 Jan 2022
Platinum-Sensitive Ovarian Carcinoma	Phase 3	US	Clovis Oncology UK Ltd.	30 Jan 2022
Platinum-Sensitive Ovarian Carcinoma	Phase 3	US	The Gynecologic Oncology Group	30 Jan 2022
Platinum-Sensitive Ovarian Carcinoma	Phase 3	US	European Society of Gynaecological Oncology	30 Jan 2022
Clear Cell Adenocarcinoma	Phase 3	DE	Clovis Oncology, Inc.	08 Jun 2020
Metastatic castration-resistant prostate cancer	Phase 3	US	Pharma& Schweiz GmbH	13 Jun 2017
Metastatic castration-resistant prostate cancer	Phase 3	AU	Pharma& Schweiz GmbH	13 Jun 2017
Metastatic castration-resistant prostate cancer	Phase 3	BE	Pharma& Schweiz GmbH	13 Jun 2017
Metastatic castration-resistant prostate cancer	Phase 3	CA	Pharma& Schweiz GmbH	13 Jun 2017
Metastatic castration-resistant prostate cancer	Phase 3	DK	Pharma& Schweiz GmbH	13 Jun 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01074970 (BRE09-146, CTgov)	Phase 2	Triple Negative Breast Cancer	135	Cisplatin (Arm A: Cisplatin Monotherapy)	yjweaxudqy(lnjbzmlqqn) = ykghhlacfc fdvzvwlbdk (kfkxyvqxcv, tfkikwcxhs - wtalopnbrt) View more	-	19 Sep 2024
				Rucaparib+Cisplatin (Arm B: Combination Therapy)	yjweaxudqy(lnjbzmlqqn) = lduoyctokv fdvzvwlbdk (kfkxyvqxcv, zdtqjktjss - krmxykeedj) View more
NCT03845296 (S1900A, ESMO2024)	Phase 2	Non-Small Cell Lung Cancer HRDsig+ \| BRCA1/2 biallelic alterations	59	Rucaparib	ojeirsvakw(vnzgwsvetr): HR = 0.5 (95% CI, 0.27 - 0.95), P-Value = 0.033 View more	Positive	14 Sep 2024
				Placebo
NCT03639935 (BilT-02, CTgov)	Phase 2	Advanced Bile Duct Carcinoma	32	Nivolumab+Rucaparib	usdcbadnww(lhwoltecxt) = dzamxutnic sqfyxtixxm (ffozbaupda, ydtcfxseco - kjheynlrac) View more	-	21 Aug 2024
NCT03617679 (CTgov)	Phase 2	Metastatic endometrial cancer \| Recurrent Endometrial Cancer	79	Rucaparib (Active Ingredient)	pcmntrxbvx(ynzetlbceg) = rhkoakydai txlcukfbbe (xmsjadcgcp, qfysojiqwf - unxbdlnrwz) View more	-	01 Jul 2024
				Placebo Oral Tablet (Placebo)	pcmntrxbvx(ynzetlbceg) = aoahvpvcwl txlcukfbbe (xmsjadcgcp, ijcvkamcav - ydjctujlhd) View more
NCT03522246 (ATHENA-MONO, ESMO_GCC2024) Manual	Phase 3	Ovarian Cancer First line	538	Rucaparib (Overall)	ydkglacung(jlkqvxziri) = oqgqqkxzwy sobeehowed (vkydlwxidn ) View more	Positive	21 Jun 2024
				Placebo (Overall)	ydkglacung(jlkqvxziri) = negksbwrcc sobeehowed (vkydlwxidn ) View more
NCT03522246 (ATHENA-MONO (GOG-3020/ENGOT-ov45), ASCO2024)	Phase 3	Ovarian Cancer Maintenance	-	Rucaparib 600 mg BID	mkdcbygpdl(dvupzholtv) = 28.7% vs 0% gdhiekpkjj (dujfxguryo ) View more	Positive	24 May 2024
				Placebo
NCT04676334 (CATCH-R, CTgov)	Phase 3	Malignant Solid Neoplasm \| Metastatic castration-resistant prostate cancer \| Ovarian Epithelial Carcinoma ... View more	34	Rucaparib	emqniwyurt(wbinnmmkcy) = tvjvhusznn lwcefwruax (clgneuzzsp, xwrgnckxga - rswtddvpqi) View more	-	07 May 2024
NCT03533946 (ROAR, CTgov)	Phase 2	Castration-Resistant Prostatic Cancer	7	Rucaparib	wvyrfhzeom(drvxzlhtxe) = ydejftrvvq ypxfqchogt (ddcqwdtdfk, sqpzpmugjl - nhtreyliyk) View more	-	13 Mar 2024
NCT03522246 (ATHENA-MONO, ESGO2024) Manual	Phase 3	Ovarian Cancer Maintenance \| First line	538	Rucaparib 600 mg BID	twlibieklr(lhbjryvyai) = cypkpoveji owyhozmfcq (avhpsjxpol ) View more	Positive	10 Mar 2024
				Placebo	twlibieklr(lhbjryvyai) = tbwrvzoeci owyhozmfcq (avhpsjxpol ) View more
NCT03533946 (Pubmed) Manual	Phase 2	Prostatic Cancer BRCA2 Mutation \| Homologous Recombination Deficiency Positive \| BRCA1	7	Rucaparib 600 mg	cijfdkkfwz(ugpuekfanb) = qptujabqyg xieisaidab (hdvnenguzy, 0 - 85.11) View more	Positive	07 Mar 2024

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