EMA
CHMP Recommends BMS' Opdivo Plus Chemo for First-Line PD-L1-Positive Gastric Cancers
The recommendation is for a narrower indication than is allowed in the US, where the FDA approved the regimen for patients regardless of PD-L1 status.
CHMP Recommends Merck's Keytruda Plus Chemo for PD-L1-Positve TNBC
The committee recommended the combo for PD-L1-positive advanced cancers based on data from the Phase III KEYNOTE-355 trial.
Instil Bio to Begin Phase II Trial of TIL Therapy for Advanced Melanoma
The firm expects data from the trial to support regulatory filings for its autologous tumor-infiltrating lymphocyte treatment in the US and EU.
The University of Modena and Reggio Emilia spinoff is awaiting word from European regulators so it can start the first human trial of its autologous MSC-based gene therapy.
CHMP Recommends BMS CAR T-Cell Therapy Abecma for Multiple Myeloma
The treatment is the first CAR T-cell therapy to receive a positive CHMP opinion for multiple myeloma patients in the EU.