Takeda pulls lung cancer drug Exkivity from U.S. market

Takeda Pharmaceuticals announced that it's working with the FDA to voluntarily withdraw its targeted non-small cell lung cancer (NSCLC) drug mobocertinib (Exkivity) in the U.S. after the Phase 3 EXCLAIM-2 confirmatory trial failed to meet its primary endpoint and thus didn't fulfill the confirmatory data requirements of FDA's Accelerated Approval Program. The drug had been approved for adult NSCLC patients with EFGR exon20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy.