European Medicines Agency
EMA's CHMP Backs Approval for Enhertu, Lynparza for Two Breast Cancer Indications
An EMA committee recommended Enhertu as a second-line drug for metastatic HER2-positive breast cancer and Lynparza as an adjuvant therapy for certain early-stage patients.
European Commission Approves Novartis MET Inhibitor Tabrecta for Advanced NSCLC
The agent is approved for non-small cell lung cancer patients in Europe whose tumors harbor METex14 skipping and who received prior immunotherapy and/or chemo.
Daiichi Sankyo's Application for Enhertu in HER2-Low Breast Cancer to Commence European Review
If the new application is approved, it would expand the market for Enhertu to include about half of all metastatic breast cancers.
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.