FDA advisory committees reject Otsuka's PTSD drug combo and GSK’s Blenrep amid safety concerns

The FDA's advisory committees recently voted negatively on two noteworthy drug candidates. The Psychopharmacologic Drugs Advisory Committee voted 10-1 against Otsuka Pharmaceutical’s combination of Rexulti and Zoloft for PTSD, citing a failed Phase 3 trial and lack of efficacy data. Separately, the Oncologic Drugs Advisory Committee voted against GSK's multiple myeloma antibody-drug conjugate Blenrep in combination therapies due to concerns about high ocular toxicity, dosing issues, and limited U.S. patient enrollment in key trials. These setbacks highlight the challenges faced in gaining regulatory approval for complicated combination therapies with safety signals.