The FDA has accepted the sBLA for Imfinzi and granted Priority Review in the US for a new four-week, fixed-dose regimen for NSCLC and bladder cancer-AstraZeneca.

Merck Inc., known as MSD outside of the United States and Canada, announced that the European Commission (EC) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults.

Merck Inc., known as MSD outside of the United States and Canada, announced that the Phase III KEYLYNK-006 trial evaluating Keytruda, Merck’s anti-PD-1 therapy, in combination with maintenance Lynparza, a PARP inhibitor, did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).