AstraZeneca India, a biopharmaceutical company, on Friday said that it had received the Drugs Controller General of India (DCGI) approval to market its drug Lynparza (Olaparib) as a monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2- negative high-risk early breast cancer.
The use will be restricted to patients who have previously been treated with neoadjuvant or adjuvant chemotherapy. It is also approved for use in the United States, European Union, Japan, and other countries.
“We are constantly pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. The regulatory approval of Lynparza, the first and only drug targeting BRCA mutations in early breast cancer, reinforces our growing capabilities in innovation and clinical research for providing holistic solutions for cancer treatment in India,” said Gagandeep Singh, Managing Director and Country President, AstraZeneca India.
Meaningful improvement
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.
Dr. Anil Kukreja, Vice President, Medical Affairs and Regulatory, AstraZeneca India, said, “The new data from the OlympiA Phase III trial also confirms that it significantly extends the lives of the patients. The approval will provide oncologists with a potential therapeutic option to be given with curative intent to eligible early breast cancer patients.”