📢 JCA UPDATE AUGUST

We’ve analyzed actual JCA procedures resulting from the Committee for Medical Products for Human Use (CHMP). Please find attached our list of ongoing joint clinical assessments (JCAs) with data extracted on 11^th August 2026.

 

💡 Here are our key findings:

🔹 Itvisma (Onasemnogene abeparvovec, Novartis): EC Decision/MA on 30.06.2026. Intrathecal spinal muscular atrophy (SMA) gene therapy for children two years and older, teenagers and adults who have 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene; ATMP.

🔹 Etcamah (Camizestrant, AstraZeneca): EC Decision/MA on 20.07.2026. Oral SERD for ESR1-mutated HR+/HER2- breast cancer in combination with a CDK4/6 inhibitor; Oncology product.

🔹 Catequentinib (Advenchen Laboratories): CHMP negative opinion on 23.07.2026; the associated JCA had already been discontinued in June 2026. One of the first JCA discontinuations due to dossier deficiencies; no JCA report, marketing authorisation refused.

🔹 Lurbinectedin (PharmaMar) & Tarlatamab (Amgen): JCA reports published on 08.07.2026 (the 2nd and 3rd JCAs overall), both in ES-SCLC. 1 PICO (Lurbinectedin) vs. 7 PICOs (Tarlatamab). In both procedures, all PICOs were addressed by PharmaMar and Amgen respectively.

🔹 Rezvilutamide (Jiangsu Hengrui Pharmaceuticals) & Mezigdomide (BMS): MAA validated on 18.06.2026 (prostate cancer and multiple myeloma respectively); Oncology products.

🔹 Daraxonrasib (Revolution Medicines): Under EMA phased review since 07.07.2026, RAS inhibitor for metastatic PDAC, orphan. It will be interesting to see how this phased review impacts the JCA process and timelines.

🔹 Bilayer Engineered Skin (Biodan Yelah S.L.): MAA validated on 16.07.2026. Tissue-engineered skin construct made of autologous keratinocytes and allogeneic fibroblasts for the treatment of adults and children with partial deep dermal and full-thickness burns; ATMP.

 

🙏 Thanks to our partners for the regulatory insights.