Cancer Drug AC Will Examine Merck, GSK Products With Different Effects on Survival Rates

FDA reviewers appear skeptical about the risk-benefit profile for Merck’s cancer maintenance candidate Taltorvic. The drug provides a “small difference” in survival over current therapies with a similar safety profile, according to briefing documents released ahead of Tuesday’s advisory panel meeting. The agency’s Oncologic Drugs Advisory Committee will vote on whether to recommend approval for Taltorvic (ridaforolimus) as a maintenance therapy for metastatic soft tissue sarcoma and bone sarcoma in patients who have had at least four cycles of chemotherapy without disease progression.
Drug Industry Daily