📢 𝗝𝗖𝗔 𝗨𝗣𝗗𝗔𝗧𝗘 𝗢𝗖𝗧𝗢𝗕𝗘𝗥

Here we go again! We’ve analyzed the ongoing JCA procedures following the CHMP monthly meeting of 12 to 15 October 2026, based on publicly available information.

Have a look at our updated list of ongoing JCAs.

 

💡 Following the key updates:

Positive CHMP opinion following a phased review: Revolution Medicines’ Rasonque (daraxonrasib) for adults with metastatic pancreatic adenocarcinoma who have received at least one previous treatment. Identified as a high-priority medicine under EMA’s Cancer Medicines Pathfinder, daraxonrasib is progressing through an accelerated regulatory review alongside its JCA, initiated in July 2026 and led by IQWiG (Germany), with the Danish Medicines Council as co-assessor.

🔹 4 new MAA validations and JCAs:
➡️ Novartis’ pelabresib, for myelofibrosis
➡️ Elevar Therapeutics’ lirafugratinib, for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma
➡️ Ultragenyx’ Fayuvi (rebisufligene etisparvovec), a gene therapy for mucopolysaccharidosis type IIIA (Sanfilippo syndrome type A)
➡️ Hengrui Pharma’s Wevdury (fuzuloparib), in combination with abiraterone acetate and prednisone or prednisolone, for metastatic castration-resistant prostate cancer

🔹 Day 120 List of Questions:
➡️ Hengrui Pharma’s rezvilutamide, for high-volume metastatic hormone-sensitive prostate cancer (mHSPC)
➡️ Bristol Myers Squibb’s mezigdomide, for relapsed or refractory multiple myeloma

🔹 Day 180 List of Outstanding Issues: BeOne Medicines’ sonrotoclax, for relapsed or refractory mantle cell lymphoma (MCL).

🔹 JCA discontinued: Innovent Biologics’ sintilimab, co-developed with Eli Lilly. The dossier failed to meet the requirements laid down in Article 9(2), (3) and (4) of Regulation (EU) 2021/2282. Key deficiencies included missing study characteristics, incomplete outcome and follow-up information, and substantial gaps in the reporting of results used for indirect treatment comparisons.

 

🙏 Thanks to our partners for the regulatory insights.

 

𝘋𝘪𝘴𝘤𝘭𝘢𝘪𝘮𝘦𝘳: 𝘖𝘶𝘳 𝘢𝘯𝘢𝘭𝘺𝘴𝘪𝘴 𝘪𝘴 𝘤𝘰𝘮𝘱𝘪𝘭𝘦𝘥 𝘶𝘴𝘪𝘯𝘨 𝘱𝘶𝘣𝘭𝘪𝘤𝘭𝘺 𝘢𝘷𝘢𝘪𝘭𝘢𝘣𝘭𝘦 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯. 𝘛𝘩𝘦 𝘭𝘪𝘴𝘵 𝘰𝘧 𝘰𝘯𝘨𝘰𝘪𝘯𝘨 𝘑𝘊𝘈𝘴 𝘢𝘯𝘥 𝘱𝘳𝘰𝘤𝘦𝘥𝘶𝘳𝘢𝘭 𝘴𝘵𝘢𝘵𝘶𝘴𝘦𝘴 𝘳𝘦𝘧𝘭𝘦𝘤𝘵 𝘰𝘶𝘳 𝘢𝘯𝘢𝘭𝘺𝘴𝘪𝘴 𝘢𝘵 𝘵𝘩𝘦 𝘵𝘪𝘮𝘦 𝘰𝘧 𝘥𝘢𝘵𝘢 𝘦𝘹𝘵𝘳𝘢𝘤𝘵𝘪𝘰𝘯. 𝘗𝘳𝘰𝘤𝘦𝘥𝘶𝘳𝘢𝘭 𝘵𝘪𝘮𝘦𝘭𝘪𝘯𝘦𝘴 𝘢𝘳𝘦 𝘴𝘶𝘣𝘫𝘦𝘤𝘵 𝘵𝘰 𝘤𝘩𝘢𝘯𝘨𝘦. 𝘞𝘦 𝘥𝘰 𝘯𝘰𝘵 𝘨𝘶𝘢𝘳𝘢𝘯𝘵𝘦𝘦 𝘵𝘩𝘦 𝘢𝘤𝘤𝘶𝘳𝘢𝘤𝘺 𝘰𝘳 𝘤𝘰𝘮𝘱𝘭𝘦𝘵𝘦𝘯𝘦𝘴𝘴 𝘰𝘧 𝘵𝘩𝘦 𝘪𝘯𝘧𝘰𝘳𝘮𝘢𝘵𝘪𝘰𝘯 𝘱𝘳𝘰𝘷𝘪𝘥𝘦𝘥 𝘩𝘦𝘳𝘦.