CHMP Updates - March'26

Highlights from the CHMP Mar 2026 Meeting are out!

New Medicines

💊 Ferring Pharmaceuticals’ nadofaragene firadenovec gene therapy for the Tx of adults with BCG-unresponsive NMIBC with CIS with/without papillary tumours

💊 Amgen's tarlatamab (DLL3 x CD3 BsAb) for the Tx of adults with ES-SCLC, who require systemic therapy following disease progression on or after 1L Tx with platinum-based chemo

💊 PharmaMar & Jazz Pharmaceuticals' lurbinectedin (alkylating agent) + atezolizumab for the maintenance Tx of adults with ES-SCLC whose disease has not progressed after 1L atezolizumab + carboplatin + etoposide induction therapy

Key Indication Expansions

💊 Pfizer's inotuzumab ozogamicin (CD22 ADC) for paediatric patients ≥1 year with CD22+ B cell precursor ALL: in first relapse after allo-HSCT; after any first relapse in patients with VHR disease; after a second or greater relapse; and in those with refractory disease. Patients with Ph+ disease should have exhausted relevant BCL-ABL targeting Tx options

💊 Shanghai Henlius’ serplulimab (anti-PD-1) + chemo for the 1L Tx of adults with unresectable, locally advanced, recurrent or metastatic oesophageal squamous cell carcinoma with PD-L1 CPS ≥5, and for the 1L Tx of adult, locally advanced or metastatic, non-squamous NSCLC patients with no EGFR, ALK or ROS1 positive mutations

💊 Novartis' trametinib (MEK1/2 inhibitor) + dabrafenib (BRAF inhibitor) for the Tx of adults with BRAF V600E+ locally advanced or metastatic differentiated thyroid cancer, refractory to or not eligible for radioactive iodine who have progressed during or after prior systemic Tx

💊 The CHMP adopted an extension of an existing Melanoma indication to adolescents ≥12 years

➡️ Trametinib ± dabrafenib for the Tx of adults and adolescents aged ≥12 years with BRAF V600+ unresectable or metastatic melanoma

➡️ Trametinib + dabrafenib for the adjuvant Tx of adults and adolescents aged ≥12 years with BRAF V600+ stage III melanoma

💊 The CHMP adopted changes to the existing indications for Eli Lilly and Company's selpercatinib (RET receptor TKI) as follows:

➡️ Selpercatinib for the Tx of adults with advanced RET+ NSCLC not previously treated with a RET inhibitor

➡️ Selpercatinib for the Tx of adults and paediatric patients ≥2 years with

 - Advanced RET+ thyroid cancer who are radioactive iodine-refractory

 - Advanced RET-mutant medullary thyroid cancer

💊 Selpercatinib for the Tx of adults and paediatric patients ≥2 years with advanced RET fusion-positive solid tumours, when Tx options not targeting RET provide limited clinical benefit, or have been exhausted

👉 Looking for more details on these recommendations, their registrational trial design and outcomes, and impact on the landscape? Reach out to us at

support@oncofocus.com, and we will take it from there.

🌐  Reference: https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2026