Breakthrough therapy designation for Lynparza (olaparib)for BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer.- AstraZeneca

AstraZeneca announced that the FDA has granted Breakthrough Therapy designation (BTD) for the oral poly ADP-ribose polymerase (PARP) inhibitor Lynparza (olaparib), for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic Castration Resistant Prostate Cancer (mCRPC) in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent (abiraterone or enzalutamide).

The FDA criteria for BTD require preliminary clinical evidence that demonstrates a drug may have substantial improvement on at least one clinically significant endpoint over available therapy. The decision to assign a BTD for Lynparza is based on the results of the TOPARP-A Phase II trial, which found that Lynparza (olaparib) monotherapy in mCPRPC may offer substantial improvement over available therapies for the treatment of the biomarker-selected population with this serious and life-threatening condition.

The TOPARP-A Phase II trial was presented at AACR 2015 and published in the New England Journal of Medicine in October 2015. It showed that men with prostate cancer with defective DNA damage repair mechanisms responded to Lynparza (olaparib).