CHMP
Novartis Nabs European Approval for Kymriah in Follicular Lymphoma
The European Commission approved the autologous CAR T-cell therapy for relapsed or refractory follicular lymphoma patients after two or more prior treatments.
EMA's CHMP Recommends Novartis' Tabrecta for Previously Treated NSCLC With METex14 Skipping Mutation
The European Commission will review the committee's recommendation and decide whether to approve the MET inhibitor for this indication in Europe.
EMA's CHMP Issues Positive Recommendation for Merck's Keytruda in PD-L1-Expressing Cervical Cancers
The European Commission will now review CHMP's opinion and decide whether to approve the Keytruda-containing regimen by the second quarter of this year.
EMA's CHMP Issues Positive Recommendation for Merck's Keytruda in Specific MSI-H/dMMR Tumors
The European committee's recommendation is narrower than the FDA's tissue-agnostic approval for the drug in refractory patients with tumors harboring these biomarkers.
EMA's CHMP Issues Positive Recommendations for Novartis' Kymriah, Janssen's Carvykti
The European Commission will review CHMP's opinions and decide whether to approve the treatments for advanced follicular lymphoma and multiple myeloma patients in the EU.