AstraZeneca Pharma India Limited has received significant regulatory approval under Form CT-20 from the Central Drugs Standard Control Organisation (CDSCO). This allows the company to import, sell and distribute Olaparib film-coated tablets (100 mg & 150 mg), marketed as Lynparza, for a new indication.
Olaparib, in combination with Durvalumab, is now approved for the maintenance treatment of adult patients with advanced or recurrent endometrial cancer. This applies to cases where the disease has not progressed following first-line treatment with Durvalumab and platinum-based chemotherapy.
This approval enables AstraZeneca to introduce Lynparza for this specific indication in India, pending any additional statutory clearances. It marks a key development in expanding treatment options for patients battling advanced endometrial cancer.
