FDA grants AstraZeneca’s Lynparza Breakthrough Therapy designation
Lynparza was designed to be taken orally to treat metastatic Castration Resistant Prostate Cancer (mCPRPC) that has been mutated by the BRCA1/2 or ATM genes. The product is designed for patients who have previously received taxane-based chemotherapy and either of the hormone agents abiraterone or enzalutamide.
The BTD requirements state that the product must consist of evidence proving that the drug can vastly improve a single noteworthy endpoint or the overall therapy. Lynparza received the BTD because of the results of the TOPARP-A Phase II trial. During this trial, Lynparza proved that it could provide an improvement to the conditions of mCPRPC when compared to available treatment therapies. The results of the trial were shown at the American Association for Cancer Research 2015 meeting and later published in the New England Journal of Medicine last October. It stated that men with prostate cancer that had damaged their DNA responded positively to Lynparza. Because of the success Lynparza had in this particular patient population, the FDA will speed up the BTD process to allow the product to be reviewed within 60 days.