VALIENT: Phase 1 Clinical Trial of VorAsidenib in Combination With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and/or IDH2 Mutations

This phase I study will evaluate the safety and tolerability of vorasidenib in combination with lomustine and determine the recommended combination dose (RCD) of vorasidenib in adults with recurrent IDH1- or IDH2-mutant glioma. The study consists of a dose de-escalation phase followed by a dose-expansion cohort to further evaluate safety and preliminary clinical activity.

Start Date30 Nov 2026

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT07811297

/ Not yet recruitingPhase 1/2

Phase 1b/2a Clinical Study of Catequentinib Hydrochloride (AL3818) Monotherapy or Combining Therapy With Other Anti-tumor Agents in Advanced, Metastatic Endometrial, Low Grade Serous Ovarian Cancer (LGSOC), STS or GBM Cancers

This phase 1b/2a study evaluates the investigational oral drug catequentinib hydrochloride (AL3818), given alone or with AL58805, temozolomide, or lomustine (CCNU), in adults with advanced or metastatic solid tumors. The phase 1b part will identify doses that can be given safely based on side effects during the first treatment cycle. The phase 2a part will estimate whether the treatments shrink non-brain tumors or keep glioblastoma from worsening for at least 6 months.
The study is open label, which means participants and study investigators will know which treatment is given. Tumor response will be assessed with RECIST version 1.1. The study will also evaluate how the investigational drugs move through the body, the duration of tumor response, progression-free survival, overall survival, and treatment safety.

Start Date01 Sep 2026

Sponsor / Collaborator

Advenchen Laboratories LLC

NCT07632209

/ Not yet recruitingPhase 2IIT

A Single-arm, Phase II Interventional Study to Evaluate the Efficacy and Safety of Lomustine Combined With Anlotinib in Patients With Extensive-stage Small Cell Lung Cancer Resistant to Second-line and Further Lines of Treatment

This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.

Start Date01 Jun 2026

Sponsor / Collaborator

Shanghai Pulmonary Hospital

100 Clinical Results associated with Lomustine

100 Translational Medicine associated with Lomustine

100 Patents (Medical) associated with Lomustine

2,740

Literatures (Medical) associated with Lomustine

01 Dec 2026·FUNCTIONAL & INTEGRATIVE GENOMICS

Comprehensive study of the tumor immune microenvironment and the prognostic significance of reticulocalbin-1: a pan-cancer analysis

Article

Author: Liu, JunZhi ; Wang, JiWei ; Sun, QingYuan ; Yang, Ning ; Wang, Xinyu ; Zhao, JiangLi ; Huang, Bin ; Liu, XuChen ; Xue, ZhiWei ; Li, Chao ; Peng, ShuJie

Reticulocalbin-1 (RCN1), an endoplasmic reticulum (ER)-related gene, demonstrates critical regulatory functions in cellular growth. RCN1 has been previously revealed to be closely associated with initiation, metastasis and chemosensitivity in some tumors. However, the prognostic significance of RCN1 and its influence on the cancer immune microenvironment remains unclear. By leveraging multi-omics data from TCGA and GEO, this study delineated the expression profile of RCN1 across various human malignancies and normal tissues. Analysis of RCN1 expression in correlation with tumor immune microenvironment characteristics was performed using CIBERSORT and ssGSEA. Pan-cancer prognostic value was assessed via multiple survival models. In glioma, immunohistochemistry, co-culture, and qPCR were utilized to further investigate the role of RCN1 in tumor immunity and prognosis. Drug-specific responses to RCN1 expression were probed for cisplatin, irinotecan, carmustine and lomustine, which are the common chemotherapeutic agents used in glioma clinical treatment. The results indicate that RCN1 is a key gene with the potential to promote the progression of multiple tumors and is closely associated with tumor immune response, particularly macrophage activation. In glioma, overexpression of RCN1 promotes tumor proliferation and indicates poor prognosis, and is closely related to endoplasmic reticulum stress. Knockdown of RCN1 enhances the chemotherapeutic efficacy of carmustine and lomustine. In conclusion, our research positioned RCN1 as an important oncogene from a pan-cancer perspective and validated its role in glioma. In particular, RCN1 is closely associated with the immune microenvironment and endoplasmic reticulum stress during tumorigenesis. In addition, RCN1 has broad prospects in guiding tumor chemotherapy pending physiological in vivo validation.

01 Nov 2026·ANALYTICA CHIMICA ACTA

Development of a monospecific monoclonal antibody and a homogeneous chemiluminescence immunoassay for selective detection of “stopped” lomefloxacin

Article

Author: Qin, Danfeng ; Li, Zizhe ; Wen, Kai ; Wang, Zhanhui ; Pan, Yantong ; He, Tong ; Liu, Gelin

BACKGROUND:

Lomefloxacin (LOM) has been stopped from use in food-producing animals in China and is regulated at lower maximum residue limits than permitted fluoroquinolones (FQs). However, the highly conserved FQ scaffold makes conventional broad-specificity antibodies unable to discriminate LOM from related analogues, leading to frequent false-positive results in immunoassays. Therefore, the development of monospecific antibodies that selectively recognize LOM and high-throughput screening methods for monitoring LOM residues remains urgently needed.

RESULTS:

Here, a unique epitope-exposed antigen design was combined with specificity-oriented hybridoma screening to direct antibody generation toward the characteristic structural features of LOM. The obtained mAb17D9 was the first antibody with monospecificity toward LOM, exhibiting an icELISA IC₅₀ of 0.164 μg/L and cross-reactivities below 1% against 16 structurally related FQs. SPR analysis further confirmed its preferential binding to LOM, with an affinity 27.3- to 15024.0-fold higher than that for FQ analogues. Structural feature analysis and molecular interaction analysis indicated that this monospecific recognition mainly originated from preferential interactions between mAb17D9 and the characteristic groups of LOM at the N1, C7, and C8 positions. Based on mAb17D9, a homogeneous chemiluminescence immunoassay (HCLIA) was established for the rapid screening of LOM residues, achieving limits of detection of 0.077-0.136 μg/kg in various animal-derived food matrices.

SIGNIFICANCE:

This study offers a viable solution for the selective detection of a target analyte among structurally similar drugs by providing a broadly applicable strategy for generating monospecific antibodies. The established HCLIA provides a robust tool for monitoring LOM residues in animal-derived foods, enhancing surveillance efficiency and strengthening food safety assurance.

03 Oct 2026·CRITICAL REVIEWS IN ANALYTICAL CHEMISTRY

Quantifying Nitrosoureas: Comprehensive Insights into Analytical Techniques Transforming Cancer Research

Review

Author: Qader, Aryan Fathulla ; Salih, Musher Ismael ; Ali, Hoshyar Saadi ; Anwar Omer, Rebaz ; Barzani, Hemn A. H. ; Sulaiman, Seerwan Hamadameen

Nitrosoureas (NUs) are a crucial class of antineoplastic agents widely used in chemotherapy to treat various malignancies, including brain tumors, lymphomas, and metastatic cancers. Over the past decade, the clinical application of NU-based chemotherapeutic drugs has expanded significantly, leading to their administration in a larger cohort of cancer patients. Despite their therapeutic efficacy, NUs exhibit high cytotoxicity, often resulting in severe adverse effects, including myelosuppression, nephrotoxicity, and pulmonary fibrosis. Given these challenges, developing reliable, sensitive, and precise analytical techniques is essential for accurately quantifying and monitoring these drugs in biological systems. This review provides a comprehensive overview of the analytical methodologies employed over the past forty years for the detection and quantification of five widely used nitrosourea-based anticancer drugs-carmustine (BCNU), lomustine (CCNU), semustine (methyl-CCNU), nimustine (NMT), and fotemustine (FM)-along with their metabolites. The discussion encompasses spectroscopic, chromatographic (liquid chromatography, gas chromatography, and high-performance liquid chromatography), and electroanalytical techniques utilized for the analysis of these compounds in various matrices, including biological fluids (plasma, urine, and tissue samples), pharmaceutical formulations, and environmental samples. Furthermore, advancements in hybrid analytical techniques and their potential in enhancing the selectivity and sensitivity of NU detection are explored. This review aims to provide insights into the evolution of analytical approaches for nitrosourea-based drugs, highlighting their applications in pharmacokinetics, therapeutic drug monitoring, and environmental surveillance.

News (Medical) associated with Lomustine

14 Oct 2026

·www.prnewswire.com

Telix Highlights Pivotal Trials in Prostate, Brain and Renal Cancers and Next Generation Theranostics at EANM

MELBOURNE, Australia and INDIANAPOLIS, Oct. 14, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that 20 company-related abstracts will be presented at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Vienna, Austria from October 17-21, 2026. Dr. David N. Cade, Telix Group Chief Medical Officer, said, "Our expansive presence at EANM reflects the breadth and maturity of Telix's pipeline, spanning pivotal therapeutic studies, precision diagnostics and next-generation technologies. The selection of 12 abstracts for top-rated oral presentations is a strong recognition of the quality and clinical relevance of this work. We look forward to continuing this discussion at our sponsored symposium on the future of theranostics in urologic oncology." Key presentations include the Phase 3 IPAX BrIGHT trial of TLX101-Tx in recurrent glioblastoma, the Phase 3 LUTEON trial of TLX250-Tx in ccRCC, and interim results from the PTherpan-Lu trial of TLX597-Tx in mAPMR prostate cancer[1]. Topline Phase 3 data for TLX591-Px (Illuccix) PET[2] imaging of prostate cancer in Chinese men will also be presented, together with real-world experience with TLX250-Px (Zircaix[3]) in ccRCC, and research from our targeted alpha therapy and MedTech programs. As in previous years, Telix will support the EANM Sanjiv Sam Gambhir Young Investigator Award, in memory of an extraordinary man and inspiring educator. Visit booth #527 to explore opportunities for collaboration with Illuccix® (kit for the preparation of gallium-68 gozetotide injection), Telix's commercial PSMA-PET imaging[4] agent in Europe; our theranostic pipeline; and our medical technologies, including the SENSEI® miniature drop-in gamma probe, QDOSE® dosimetry software and artificial intelligence (AI). EANM presentation details are as follows (all times CEST): Sponsored Symposium Title: The future doesn't wait: The next era of theranostics in urologic oncology. Date & Time: 18-Oct-26, 13:15 – 14:45 Location: Hall F2, Austria Center Vienna Chair: J. Calais, Gustave Roussy, IGR and Université Paris-Saclay, Paris, France Agenda: The theranostic revolution J. Calais The evolving role of PSMA-PET in prostate cancer K. Herrmann, University Hospital Essen, Germany M. Ghesani, United Theranostics, USA Next-generation PSMA therapeutics: Overcoming today's challenges D. Oprea-Lager, Radboud University Medical Center, Nijmegen, the Netherlands L. Emmett, St Vincent's Hospital, Sydney, Australia Panel discussion - all Extending prostate cancer theranostic success to broader GU diseases J. Calais Oral presentations Title: ELEGANCE, Prospective pilot study, assessing imaging performance of TLX250-Px ([⁸⁹Zr]Zr-girentuximab) PET/CT in Patients with Hepatocellular Carcinoma, Biliary Tract Cancer or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms (NCT06735560) Date and Time: 18-Oct-26, 08:00 – 09:30 Presenter: Clement Bailly, CHU Nantes Abstract #: OP-036 Title: HIMIKO, TLX591-Px ([⁶⁸Ga]Ga-PSMA) PET/CT in Hepatocellular Carcinoma: impact of Multiparametric dynamic whole-body imaging and kinetic modelling (NCT06999837) Date and Time: 18-Oct-26, 08:00 – 09:30 Presenter: Rachel Bardy, CHU Nantes Abstract #: OP-041 Title: Exploring carbonic anhydrase IX as a diagnostic imaging target using TLX250-Px ([⁸⁹Zr]Zr-girentuximab) in Von Hippel-Lindau Disease: preliminary results from the CAT-VHL Phase 2 trial (NCT07171905) Date and Time: 18-Oct-26, 15:00 – 16:30 Presenter: Fabrizia Gelardi, San Raffaele Hospital Abstract #: OP-168 Title: LUTEON, Phase 3 study to assess safety and efficacy of TLX250-Tx (¹⁷⁷Lu-girentuximab) in advanced, relapsed or recurrent ccRCC (NCT07197580) Date and Time: 18-Oct-26, 15:00 – 16:30 Presenter: Ghoufrane Tlili, CHU Bordeaux Abstract #: OP-170 Title: Building the traceability backbone for radiopharmaceutical therapy, first results from the PDIB Secondary Standards Laboratory Network Date and Time: 19-Oct-26, 08:00 – 09:30 Presenter: Steven Graves, University of Iowa Abstract #: OP-291 Title: Optimizing SPECT/CT for alpha emitters: Phantom validation and calibration of [²¹¹At] imaging Date and Time: 19-Oct-26, 08:00 – 09:30 Presenter: Rob van Rooij, UMC Utrecht Abstract #: OP-294 Title: IODO-RISE, TLX101-Tx (iodofalan-¹³¹I) in recurrent high-grade glioma, investigation of safety and efficacy Date and Time: 19-Oct-26, 08:00 – 09:30 Presenter: Tim Sturre, UMC Utrecht Abstract #: OP-311 Title: IPAX BrIGHT, Pivotal study of TLX101-Tx (iodofalan-¹³¹I) with or without lomustine vs lomustine alone for the treatment of patients with radiographically confirmed recurrent glioblastoma at first recurrence (NCT07100730) Date and Time: 19-Oct-26, 08:00 – 09:30 Presenter: Nelleke Tolboom, UMC Utrecht Abstract #: OP-312 Title: Comparative evaluation of TLX252-Tx ([²²⁵Ac]Ac-) and TLX250-Tx ([¹⁷⁷Lu]Lu-DOTA-hG250) targeted radionuclide therapy and combination with PD1 blockade in a preclinical renal cell carcinoma model Date and Time: 19-Oct-26, 16:45 – 18:15 Presenter: Twan van der Werff, UMC Radboud Abstract #: OP-478 Title: Interim results from PTherpan-Lu trial: TLX597-Tx ([¹⁷⁷Lu]Lu-panPSMA) radionuclide therapy for patients with mCRPC[5] Date and Time: 19-Oct-26, 16:45 – 18:15 Presenter: Yehia Omar, Misr Radiology Abstract #: OP-523 Title: Integration of spatial analysis and deep learning for enhanced tumor classification in total-body PET/CT imaging: using residual deep learning with spatial feature augmentation and cross-validated ensemble learning Date and Time: 20-Oct-26, 09:45 – 11:15 Presenter: Simon Wail, Telix Pharmaceuticals Abstract #: OP-613 Title: TLX250-Px ([⁸⁹Zr]Zr-girentuximab) PET/CT for characterization of indeterminate renal masses, diagnostic performance and clinical impact in a real-world cohort Date and Time: 20-Oct-26, 09:45 – 11:15 Presenter: Sazan Rasul, Medical University of Vienna Abstract #: OP-627 ePosters Title: QDOSE® allometry-guided human dosimetry of TLX102-Tx ([²¹¹At]APA): Impact of administration route on maximum tolerated activity Abstract #: EP-0067 Title: Illuccix China, preliminary results from Phase 3 trial of TLX591-Px (⁶⁸Ga-PSMA-11) PET for detection of biochemical recurrence of prostate cancer in Chinese men (NCT05847348) Abstract #: EP-0460 Title: TLX250-Px (⁸⁹Zr-girentuximab) PET/CT in Von Hippel Lindau disease; initial real-world experience in VHL expert center Abstract #: EP-0595 Title: TLX250-Px (⁸⁹Zr-girentuximab) PET/CT in clear cell renal cell carcinoma, impact on staging and clinical management Abstract #: EP-0599 Title: Impact of TLX250-Px (⁸⁹Zr-girentuximab) based radionuclide imaging in patients with renal cell carcinoma on virtual tumor board decision making Abstract #: EP-0606 Title: A semi-mechanistic population biodistribution model of TLX250-Px (⁸⁹zr-girentuximab) for the diagnosis of clear cell renal cell carcinoma Abstract #: EP-0999 Title: Potential for radioguided surgery based on internal conversion electron detection using a compact CMOS detector Abstract #: EP-1070 Title: A dosimetric study of bladder endocavitary therapy using astatine-211 Abstract #: EP-1239 About Telix Pharmaceuticals Limited Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease. Telix's commercial franchise is anchored by its precision diagnostics portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S., and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA) for prostate imaging, and Pixclara® (floretyrosine F 18) approved by the FDA for glioma imaging. The Company's late-stage therapeutic pipeline includes three investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (iodofalan 131I) in recurrent glioblastoma, and TLX250-Tx (lutetium (177Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation candidates. Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit or follow Telix on LinkedIn,X and Facebook. Investor Relations Annie Kasparian [email protected] Charlene Jaw [email protected] Media Eliza Schleifstein 917.763.8106 (Mobile) [email protected] Legal Notices Cautionary Statement Regarding Forward-Looking Statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, including TLX250-Px, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 21% more press release views with Request a Demo

Phase 3Clinical ResultPhase 2Drug Approval

15 Jul 2026

·www.prnewswire.com

Septa Pharmaceuticals Inc. Acquires CeeNU® (Lomustine) from Bristol Myers Squibb, Canada

Mississauga, ON, July 15, 2026 /PRNewswire/ - Septa Pharmaceuticals Inc., a rapidly growing leader in the Canadian healthcare sector, is proud to announce the successful acquisition of CeeNU® (Lomustine) from Bristol Myers Squibb, Canada as of June 29th, 2026. This strategic acquisition marks a significant milestone in Septa's ongoing expansion and underscores its unwavering dedication to strengthening its specialty oncology pharmaceutical portfolio. CeeNU® (Lomustine) is an established and highly valued alkylating agent utilized primarily in the treatment of specific types of brain tumors and Hodgkin's lymphoma. By integrating this essential chemotherapy medication into its product lineup, Septa is reinforcing its footprint in the critical care and oncology space. CeeNU® (Lomustine) represents an important therapeutic option for many individuals battling severe health conditions. Consequently, Septa is deeply committed to ensuring continuous, uninterrupted patient access to this vital medication across Canada. Recognizing the critical need for a robust and stable supply of essential medicines in today's complex healthcare landscape, Septa is fiercely prioritizing the long-term availability of CeeNU® (Lomustine). "As we integrate CeeNU® (Lomustine) into our growing portfolio, our primary focus remains firmly on the patients and the medical professionals who treat them," said Devinder K., President & CEO of Septa Pharmaceuticals Inc. "We are working collaboratively and closely with all relevant stakeholders, including regulatory bodies and supply chain partners, to ensure a seamless transition. This acquisition is a profound testament to our core mission of providing high-quality, reliable pharmaceutical products that tangibly improve health outcomes both across the country and globally." As Septa rapidly broadens its diverse product portfolio and expands geographic territories, the company is actively seeking new strategic partnerships and licensing opportunities. We welcome collaborations with pharmaceutical companies to out/in-license, launch and commercialize such high-impact therapies globally. Together, we can drive mutual growth and ensure vital medicines reach global markets. About Septa Pharmaceuticals Inc. Headquartered in Ontario, Canada, Septa Pharmaceuticals Inc. is a forward-thinking pharmaceutical company dedicated to the development, acquisition, and commercialization of specialized pharmaceuticals globally. With a patient-first philosophy, Septa consistently strives to bridge gaps in the healthcare market by securing and stabilizing the supply of critical medicines. Through strategic partnerships and targeted acquisitions, Septa continues to build a robust product pipeline and managed access programs designed to meet the evolving needs of the global medical community. SOURCE Septa Pharmaceuticals Inc. 21% more press release views with Request a Demo

Acquisition

15 Jul 2026

·allsci.com

Septa acquires CeeNU from BMS to end Canada’s critical chemotherapy shortage

Mississauga, Ontario-based Septa Pharmaceuticals has acquired CeeNU (lomustine) from Bristol Myers Squibb (NYSE: BMY) Canada, effective June 29, 2026, resolving a documented patient access crisis for a chemotherapy agent used in brain tumors and Hodgkin’s lymphoma that had been on Canada’s Tier 3 Drug Shortages List — the highest severity designation. The deal is not a conventional commercial transaction. BMS Canada filed a formal discontinuation notice with Health Canada in April 2024, triggering a supply gap that led to emergency importation of UK-labelled lomustine into British Columbia. No generic manufacturer stepped in despite the molecule being off-patent, leaving Septa to fill a structural market gap rather than pursue a standard specialty pharma acquisition. Lomustine is an alkylating agent in the nitrosourea class that crosslinks and damages DNA strands, inhibiting replication in rapidly dividing cancer cells. It remains a standard-of-care chemotherapy for recurrent glioblastoma and certain Hodgkin’s lymphoma regimens in Canada, with no approved targeted replacement in the recurrent glioblastoma setting. Active clinical trials continue to use it as a backbone or comparator, including a randomized Phase II trial at McGill evaluating eflornithine plus lomustine versus lomustine alone in approximately 280 patients. Financial terms were not disclosed. The absence of a headline price is consistent with the access-driven context of the deal and the modest commercial ceiling imposed by Canada’s Patented Medicine Prices Review Board, which limits the pricing upside available to Septa relative to what US acquirers have historically exercised on similar assets. The closest structural precedent is BMS’s divestiture of US lomustine rights to NextSource Biotechnology in 2013, which led to the rebranded Gleostine and a subsequent price increase of approximately 1,400% — a strategy structurally unavailable to Septa under Canadian price controls. The Canada transaction appears to complete BMS’s global exit from lomustine, a molecule the company originally developed and commercialized, consistent with its decade-long strategy of divesting off-patent chemotherapy assets to concentrate capital on immuno-oncology, cell therapy, and novel mechanisms. BMS has simultaneously been expanding its Canadian oncology presence through novel approvals, including Health Canada clearances for Breyanzi (lisocabtagene maraleucel) in second-line diffuse large B-cell lymphoma and dual immunotherapy Opdivo (nivolumab) plus Yervoy (ipilimumab) for colorectal and liver cancers. For Septa, the CeeNU acquisition represents a foundational oncology asset and establishes the company as a supply-critical provider in the Canadian market — a positioning that may facilitate future acquisitions of similarly distressed or divested oncology brands from large pharma. The company has indicated it is actively seeking further in-licensing and out-licensing opportunities globally. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

ImmunotherapyPhase 2AcquisitionDrug ApprovalCell Therapy

100 Deals associated with Lomustine

External Link

KEGG	Wiki	ATC	Drug Bank
D00363	Lomustine	L01AD02	DB01206

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bronchogenic Carcinoma	China	Nanjing Pharmaceutical Factory Co., Ltd.	01 Jan 1982
Glioma	China	Nanjing Pharmaceutical Factory Co., Ltd.	01 Jan 1982
Lymphoma	China	Nanjing Pharmaceutical Factory Co., Ltd.	01 Jan 1982
Rectal Cancer	China	Nanjing Pharmaceutical Factory Co., Ltd.	01 Jan 1982
Stomach Cancer	China	Nanjing Pharmaceutical Factory Co., Ltd.	01 Jan 1982
Brain Cancer	United States	Azurity Pharmaceuticals, Inc.	04 Aug 1976
Hodgkin's Lymphoma	United States	Azurity Pharmaceuticals, Inc.	04 Aug 1976

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EANO2026	Not Applicable	High grade glioma	214	Lomustine 90 mg/m2	cemhqazdct(vqxeshvsrg) = npomcrovoo yprrlbpcdw (hddmpwuhna, 2.7 - 4.1) View more	Positive	24 Sep 2026
				Lomustine 110 mg/m2	cemhqazdct(vqxeshvsrg) = yxjopuuwco yprrlbpcdw (hddmpwuhna, 2.6 - 4.1) View more
NCT07100730 (IPAX-BrIGHT, EANO2026)	Phase 2	Recurrent Glioblastoma	68	Iodofalan (131I) + Lomustine	ztshfgmfem(xowdhsxgmy) = nwelqmtskb pgvhzzbnoe (tolbbdrdrf )	Positive	24 Sep 2026
EANO2026	Not Applicable	Glioblastoma	152	Bevacizumab-Irinotecan	qpskkblfjs(xtblvhmsnp) = jnbzmdhzci fsksuuydgo (zbhsboccnf ) View more	Positive	24 Sep 2026
				Bevacizumab-Lomustine	qpskkblfjs(xtblvhmsnp) = oplfhyhsxh fsksuuydgo (zbhsboccnf ) View more
EANO2026	Not Applicable	Astrocytoma First line BRAF V600E	18	Radiochemotherapy with concurrent and adjuvant temozolomide (TMZ)	zuebwueklz(jdzrudbhpk) = ahiutrgspi cllloxnnwg (lcrlpwnqtt ) View more	Positive	24 Sep 2026
AAN2026	Not Applicable	Glioblastoma Multiforme MGMT promoter methylation	793	CCNU-based regimens	cclixqevaa(jowqqmyihl): HR = 0.88 (95.0% CI, 0.6 - 1.29), P-Value = 0.52 View more	Positive	25 Apr 2026
				Temozolomide-based regimens
CeTeG/NOA-09 (EANO2024)	Not Applicable	Glioblastoma MGMT-methylated \| IDH-wildtype	17	CCNU/TMZ	lddzvsdbcm(ggbwhwzrgs) = lesedayoav uurlnhtrwm (oaarobwzmm, 17.6 - not reached) View more	Positive	17 Oct 2024
CeTeG/NOA-09 (EANO2024)	Phase 3	Glioblastoma	31	Lomustine-Temozolomide Chemotherapy + Radiotherapy	srcvjsimce(ynpdjhbxnk) = glksvjzaxt jstftukgcd (rkoxzktqah )	Positive	17 Oct 2024
CTRI/2020/07/026696 (VAMANA, ASCO2024) Manual	Phase 2	Glioblastoma	46	bevacizumab+CCNU	uqblnleyol(hwstdapgdc) = dgmzglsarc irbjyuyxci (acyaqfkder, 5.474 - 6.793) View more	Positive	02 Jun 2024
EORTC 26101 (SNO2022)	Phase 2/3	Recurrent Glioblastoma	-	Lomustine alone	eapammrcpv(vpiontfcdm) = Thrombocytopenia represents the main cause of stopping chemotherapy for toxicity during the treatment of glioblastoma fjqiwzvcer (rwqmzcjiip ) View more	Negative	14 Nov 2022
				Lomustine plus bevacizumab
PROTECT (SNO2022)	Not Applicable	Low grade glioma Adjuvant 1p/19q co-deletion	20	Procarbazine, Lomustine, Vincristine (PCV)	nsqieofwyu(wqaovbbjhj) = pdwuskpowf qzvbewkwsv (xpwbgzrtus ) View more	Negative	14 Nov 2022
				Temozolomide (TMZ)	nsqieofwyu(wqaovbbjhj) = rofmsabwnk qzvbewkwsv (xpwbgzrtus ) View more

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Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis