British drugmaker AstraZeneca PLC (AZN,AZN.L) said Friday that the US Food and Drug Administration has approved Lynparza capsules, 400mg twice daily, as the first monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.
Lynparza, known chemically as olaparib, has been approved under the FDA's Accelerated Approval programme, based on existing objective response rate and duration of response data. Continued approval for the indication is contingent upon verification of clinical benefit in ongoing confirmatory Phase III trials.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. Lynparza is the first PARP inhibitor to be approved for patients with germline BRCA-mutated advanced ovarian cancer.
The efficacy of Lynparza is based on analysis of 137 patients with measurable, germline BRCA mutated advanced ovarian cancer treated with three or more prior lines of chemotherapy. The trial results showed an overall response rate of 34%, with a median response duration of 7.9 months.
by RTT Staff Writer
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