Merck said FDA has extended the action date for the supplemental Biologics License Application for Keytruda as monotherapy for the first-line treatment of locally advanced or metastatic NSCLC in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations.
More than a year after a catastrophic shortage of platinum-based chemotherapy drugs swept through the U.S., FDA on June 28 officially removed carboplatin and cisplatin from the drug shortage list.
