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 Olympi A 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.
Currently, Lynparza is the first and only approved medicine targeting BRCA (Breast Cancer gene) mutations in early-stage breast cancer.
“The regulatory approval of Lynparza…Reinforces our growing capabilities in innovation and clinical research for providing holistic solutions for cancer treatment in India,” AstraZeneca India Managing
Director and Country President Gagandeep Singh noted.
Breast cancer is one of the most diagnosed cancer worldwide with an estimated 23 lakh patients diagnosed per year.
Non-Communicable Diseases (NCDs) like cancer in India today account for 62 per cent of all deaths and 48 per cent of preventable premature deaths.
“Our oncology portfolio has been consistently growing in the range of 40 to 50 per cent over the last 3 years…At AstraZeneca, we see huge potential in the utilisation of cancer-related drugs for wider scope,” Singh stated.