A panel of U.S. Food and Drug Administration advisers on Friday voted for the restricted use of British drugmaker AztraZeneca Plc's experimental treatment, jointly developed with Merck & Co , for a type of prostate cancer.
They were withdrawn last year as second line of treatment for ovarian cancer patients after the FDA limited the use of PARP inhibitors and requested companies to pull the drug.
Friday's vote is based on a late-stage study, which showed Lynparza in combination significantly improved duration for which patients live without disease worsening when compared to the placebo in combination with abiraterone and prednisone/prednisolone. Lynparza is already approved by the FDA to treat a type of breast cancer, ovarian cancer, as well as a different form of prostate cancer.
The FDA while making its final decision on the use of the drug usually follows the recommendations of its expert panel but is not obligated to do so.Our Standards:
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