A panel of U.S. Food and Drug Administration (FDA) advisers on Friday voted for the restricted use of British drugmaker AstraZeneca Plc.’s experimental treatment, jointly developed with Merck & Co., for a type of prostate cancer.
The FDA panel voted 11–1 with one abstention, in favor of Lynparza, in combination with other medications—abiraterone and prednisone or prednisolone—as a first-line treatment for a type of treatment-resistant prostate cancer in adult patients.
However, the panel recommended the approval to be limited only to patients whose tumors have a mutation in the BCRA genes, and advised against approval beyond this patient population….