CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025
• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.
• AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics.
• Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.
Cabozantinib Shows Promise in Advanced GI Neuroendocrine Tumors
• Cabozantinib (Cabometyx) significantly improved progression-free survival (PFS) in patients with advanced gastrointestinal neuroendocrine tumors (GI-NETs) after prior therapy.
• The CABINET trial subgroup analysis revealed a median PFS of 8.5 months with cabozantinib versus 5.6 months with placebo in GI-NET patients.
• Benefits were observed across various clinical factors, including tumor grade and prior treatment, except in non-midgut GI primary tumors.
• The safety profile of cabozantinib was consistent with previous data, with manageable adverse events reported.
Novel Therapies to Watch in 2025: Oncology, Hematology, and Neurology
• Tarlatamab (Imdelltra) is set to transform small cell lung cancer treatment, targeting DLL3-expressing cells and potentially becoming the standard of care for previously treated ES-SCLC.
• Fitusiran, an antithrombin-targeting siRNA, offers a novel approach to hemophilia A or B treatment, demonstrating significant reductions in annualized bleeding rates in phase 3 trials.
• Vepdegestrant (ARV-471), a PROTAC protein degrader, shows promise in ER+/HER2- metastatic breast cancer, potentially offering a more effective protein degradation mechanism.
• Cobenfy (xanomeline and trospium chloride) represents a new class of schizophrenia treatment, selectively targeting M1 and M4 receptors, with observed improvements in clinical trials.
FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors
• The FDA has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous use, offering a new administration option for various solid tumors.
• The approval was based on the CheckMate-67T trial, demonstrating non-inferior pharmacokinetic exposures and comparable safety to intravenous Opdivo.
• Opdivo Qvantig provides a faster administration time of 3-5 minutes compared to the 30-minute intravenous infusion, enhancing patient convenience.
• This subcutaneous formulation is approved for most previously approved adult solid tumor Opdivo indications, either as monotherapy or in combination with other treatments.
Exelixis Downgraded to Market Perform Despite Price Target Increase to $40
BMO Capital Markets downgraded Exelixis Inc. from Outperform to Market Perform, raising the price target to $40 due to a cautious outlook on the company's growth prospects, despite a 56% stock gain over six months. The focus is on zanzalintinib's trial for colorectal cancer, with success probability increased to 50%, amidst uncertainties from cabometyx's mixed track record.
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