The FDA Oncologic Drugs Advisory Committee agreed with the agency’s forcefully stated view that Lynparza (olaparib), a PARP inhibitor, should be given only to metastatic castration-resistant prostate cancer patients whose tumors have a BRCA mutation.
In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
