On Friday, the Drugs Controller General of India (DCGI) has given its market approval to the drug Lynparza (Olaparib) as a monotherapy for the adjuvant treatment for BRCA-mutated HER2- negative high-risk early breast cancer. The drug has been manufactured by AstraZeneca India, a biopharmaceutical company based in Bengaluru.
As of now, drug use will be specifically restricted to adult patients treated with neoadjuvant (administration of therapeutic agents before a main treatment) or adjuvant chemotherapy. The company has reported that the drug is also approved in the United States, Japan, European Union, and other countries.

The company’s MD, Gagandeep Singh, has said that the firm is constantly trying to change the practice of medicine through advancements in science and technology. It aims to transform the lives of patients living with life-threatening disease cancer. He further stated that it is the first and only drug that targets BRCA mutations in early breast cancer.

The approval of Lynparza reinforces the firm’s growing abilities in clinical research and innovation to provide comprehensive solutions for cancer treatment in India. The regulatory approval was based on results from the OlympiA Phase III trial. It, inter alia, reported that Olaparib demonstrated a clinically meaningful and statistically significant improvement.

Headquartered in Bengaluru, AstraZeneca was founded in 1979. It is a subsidiary of AstraZeneca Plc, UK, with a workforce of over 1400 employees across the country.