DCGI approved AstraZeneca’s Lynparza as a monotherapy for adjuvant treatment of patients with high-risk early breast cancer
AstraZeneca India, a leading science-led biopharmaceutical company, today announced that it has received a 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, 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. With the DCGI’s approval, Lynparza is now approved in the US, EU, Japan, India and several other countries for the treatment of the same. Currently, Lynparza is the first and only approved medicine targeting BRCA mutations in early-stage breast cancer.
Speaking on this, Gagandeep Singh, Managing Director and Coun