AstraZeneca and Merck announced that Lynparza  in combination with abiraterone and prednisolone (abi/pred) has been approved in Japan for the treatment of adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer with distant metastasis (mCRPC).

This approval by the Japanese Ministry of Health, Labor and Welfare was based on an exploratory subgroup analysis of the Phase 3 PROpel trial.

The safety and tolerability of Lynparzaplus abi/pred in PROpel was in line with that observed in prior clinical trials and the known profiles of the individual medicines. In the ITT population, common adverse events (AEs) in patients who received Lynparza plus abi/pred were anemia (45.5%), nausea (28.1%) and fatigue (27.9%).

Mototsugu Oya, professor and chairman, department of urology, Keio University School of Medicine, Japan, said, “The PROpel trial showed that the combination of LYNPARZA plus abiraterone delivered clinically meaningful improvements in outcomes for patients with BRCAm mCRPC. With this approval, patients in Japan will now have the opportunity to benefit from this new treatment combination which has the potential to become the new standard of care for patients with BRCA mutations.”

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “This LYNPARZA combination has been shown to reduce the risk of disease progression or death compared to standard of care and underscores the critical importance of BRCA testing at metastatic diagnosis. Today’s approval is a major step forward for patients in Japan with BRCAm mCRPC who urgently need new first-line treatment options.”

Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “Prostate cancer impacts thousands of patients in Japan each year, and currently there are limited options available to those with metastatic disease. It is very important to develop and deliver novel treatment combinations to patients with BRCAm mCRPC that improve on the current standard of care.”