BRIEF—DCGI approved AstraZeneca's Lynparza

AstraZeneca India has received a Drugs Controller General of India (DCGI) approval to market Lynparza (olaparib) as a monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2-negative high-risk early breast cancer.

The approval was based on results from the OlympiA Phase III trial, which suggested that olaparib demonstrated a statistically-significant and clinically-meaningful improvement, with an overall survival benefit.

Following the approval, Lynparza is now approved in the USA, EU, Japan, India and several other countries.

Currently, it is the first and only approved medicine targeting BRCA mutations in early-stage breast cancer.

Dr Anil Kukreja, vice president, medical affairs and regulatory, AstraZeneca India said: "The marketing approval for Lynparza presents the early-stage BRCA mutated breast cancer patients in India with a new targeted therapy option. It reduces the risk of disease recurrence in these high-risk patients, and now the new data from OlympiA Phase III trial also confirms that it significantly extends the lives of the patients."