AstraZeneca prostate cancer therapy reaches major milestone

The FTSE 100 pharmaceutical firm said the Breakthrough Therapy designation for Lynparza (olapariv) in this particular patient population meant the FDA would expedite its review of submission data within 60 days of receipt.

AstraZeneca said the BTD designation was for the monotherapy treatment of BRCA1/2 or ATM gene mutated metastatic castration resistant prostate cancer, in patients who have received a prior taxane-based chemotherapy and at least one newer hormonal agent - abiraterone or enzalutamide.

The company's board said the decision to assign a BTD for Lynparza monotherapy was based on the results of the TOPARP-A Phase II trial, which found that it may offer substantial improvement over available therapies in this particular patient population.

That trial, published in the New England Journal of Medicine in October 2015, showed that men with prostate cancer with defective DNA damage repair mechanisms did respond to Lynparza.

"More than 27,000 men died of prostate cancer last year in the US alone", said Antoine Yver, head of oncology, Global Medicines Development at AstraZeneca.

"The breakthrough Therapy designation for Lynparza is encouraging news for patients and their families, as there are current;y very limited treatment options for metastatic Castration Resistant Prostate Cancer", Yver added.

Lynparza had already been approved by authorities in 40 countries for the maintenance treatment of women with BRCA-mutated ovarian cancer.

AstraZeneca said Phase III studies in gastric cancer, pancreatic cancer and adjuvant and metastatic BRCAm breast cancers were underway, with further studies planned.