AstraZeneca India Gets Approval To Market Drug Treating Breast Cancer

The Drugs Controller General of India (DCGI) has approved Lynparza (Olaparib) as a monotherapy for the treatment of adult patients with early breast cancer, who have previously been treated with neoadjuvant or adjuvant chemotherapy.

Drug firm AstraZeneca India on Friday said it has received an approval from the Drugs Controller General of India to market its drug for the treatment of breast cancer.

The Drugs Controller General of India (DCGI) has approved Lynparza (Olaparib) as a monotherapy for the treatment of adult patients with early breast cancer, who have previously been treated with neoadjuvant or adjuvant chemotherapy.

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, AstraZeneca India said in a statement.

With the DCGI's nod, Lynparza is now approved in the US, EU, Japan, India and several other countries for the treatment of early-stage breast cancer, it added.