AstraZeneca's Lynparza gets FDA Breakthrough status for prostate cancer
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for AstraZeneca’s (LSE: AZN) Lynparza (olaparib) for the treatment of prostate cancer, it has been announced.
The decision to assign BTD for Lynparza was based on the results of the TOPARP-A Phase II trial which found Lynparza offered substantial improvement as a monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer (mCRPC).
The FDA will now expedite the review of submission data for Lynparza within 60 days of receipt.
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