BRISTOL MYERS SQUIBB

Novartis' Scemblix, a first-in-class STAMP inhibitor, received FDA approval for treating chronic myeloid leukaemia (CML) in patients previously treated with two or more TKIs, and those with a T315I mutation. It offers a new option by potentially overcoming TKI resistance and side effects, bolstering Novartis' CML portfolio.

FDA advisors to review three cancer immunotherapies (Keytruda, Opdivo, Tecentriq) for potential market withdrawal after failing confirmatory trials. The review focuses on their use across six cancer types, with discussions on ongoing trials as alternative confirmatory studies. The meeting aims to gather expert and patient input on these drugs' future.

Johnson & Johnson’s Janssen unit submitted cilta-cel, a CAR-T therapy for multiple myeloma, to the FDA, targeting BCMA in heavily treated adults. Competing with BMS’s ide-cel, cilta-cel showed a 97% response rate in trials. Despite risks, including 14 deaths, it may offer long-lasting effects. BMS and others are also advancing BCMA-targeted therapies.

Johnson & Johnson's CAR-T therapy, cilta-cel, gains a six-month FDA review, potentially narrowing Bristol-Myers Squibb and bluebird bio's Abecma lead. Both target BCMA for multiple myeloma, with cilta-cel showing strong clinical results. Competition and data on earlier-line therapy use are ongoing, with Abecma ahead in Europe.

FDA approved Bristol Myers Squibb's Opdivo in a subcutaneous injection, easing treatment for patients and potentially extending its patent life. This version, Opdivo Qvantig, is approved for various cancers, offering quicker administration and possibly reducing treatment costs. It uses Halozyme's hyaluronidase technology for improved drug delivery.

FDA approved Opdivo Qvantig™, a subcutaneous injection combining nivolumab and hyaluronidase, for treating adult solid tumors. Supported by CheckMate-67T study, it showed noninferior efficacy and safety to IV Opdivo. Common side effects include fatigue and musculoskeletal pain. Offers faster delivery for cancer patients.

CytomX Therapeutics prioritizes CX-2051, a PROBODY® ADC for advanced metastatic CRC, with Phase 1a data expected in H1 2025. Organizational changes aim to extend cash runway into Q2 2026, focusing on clinical programs and partnerships. CX-904 and CX-801 also progress, with data expected in 2025.

The RELATIVITY-047 trial showed nivolumab/relatlimab significantly improved overall survival (51.0 vs 34.1 months) and progression-free survival (10.2 vs 4.6 months) in advanced melanoma patients compared to nivolumab alone, with a safety profile consistent with previous reports.

Bristol Myers Squibb's Opdivo Qvantig, an injectable cancer immunotherapy, has been FDA-approved for subcutaneous use in various cancers. It offers a quicker, more convenient administration method compared to IV, with similar efficacy and safety. Recent approvals and studies highlight Opdivo's role in enhancing cancer treatment outcomes.