USFDA panel backs restricted use of AstraZeneca Prostrate cancer drug
Lynparza belongs to a class of drugs called PARP inhibitors, which include Clovis Oncology's Rubraca and GSK Plc's Zejula.;
Cambridge: 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.
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.
The panel also recommended against approval beyond this patient population.
Its recommendation comes after Lynparza and similar class of therapies suffered a series of safety setbacks as clinical data suggested that patients do not live as long as those given chemotherapy when given as a second-line therapy.
Lynparza belongs to a class of drugs called PARP inhibitors, which include Clovis Oncology's Rubraca and GSK Plc's Zejula.
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