📢 JCA UPDATE SEPTEMBER

Here we go this month! We’ve analyzed ongoing JCA procedures resulting from the Committee for Medical Products for Human Use (CHMP), based on data extracted on 18 September 2026.

 

Have a look at our list of ongoing JCAs.                                                                                                     

💡 Following the key updates:

🔹 Positive opinion: Sepalna (Senaparib) for the Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer

🔹 Positive opinion: Lifyorli (Relacorilant) for the Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

🔹 Positive opinion (apparently without Day 180 List of Outstanding Issues): Gevalka (Ensartinib) for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC)

🔹 Day 180 LoOI + request for clock stop extension: Zopapogene imadenovec (ATMP) for the Treatment of respiratory papillomatosis in adults

🔹 Day 180 LoOI: Sintilimab for the Treatment of non-squamous non-small cell lung cancer in adults. Interestingly, the JCA procedure was discontinued on 16 September, as the European Commission considered the dossier incomplete.

🔹 Day 120 LoQ: Cosibelimab For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma

🔹 Day 120 LoQ: Lunsotogene parvec for the Treatment of biallelic OTOF variant-associated hearing loss in adults and children

🔹 New MAA start: Bifikafusp alfa / Onfekafusp alfa Neoadjuvant treatment of adult patients with melanoma

🔹 NEW JCA report endorsed: Etcamah (Camizestrant) Astra Zeneca – Treatment of adults with locally advanced or metastatic breast cancer

🔹 NEW JCA report published: Itvisma (Onasemnogene abeparvovec) – Treatment of 5q spinal muscular atrophy (SMA)

🔹 Qezzaqar (Catequentinib): The company has requested a re-examination of the EMA’s opinion issued on 23 July 2026. Upon receipt of the grounds for the request, the Agency will re-examine its opinion and issue a final recommendation. The JCA procedure was discontinued on 22 June 2025. It will be interesting to see what implications, this may have for the previously discontinued JCA process.

 

Disclaimer: Our analysis is compiled using only publicly available information and assumes a standard EMA timeline of 3 months clock stop d120 and 1-month d180, except where clock stop extensions are agreed with EMA. Subject to change without notice.

We do not guarantee the accuracy of the information provided here.