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New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India

Nov 26, 2024

On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India’s Central Drugs Standard Control Organisation (CSDCO) to market Lynparza® (olaparib) in India 

The CDSCO granted approval for the use of Lynparza® in combination with durvalumab for the maintenance treatment of advanced or recurrent endometrial cancer in adults whose disease has not progressed on first-line platinum-based chemotherapy.  Lynparza® received Indian approval in August 2022 as a monotherapy for adjuvant treatment of patients with high-risk early breast cancer. 

This follows European approval of the combination treatment in August 2024.  AstraZeneca confirmed in August 2024 that regulatory submissions for Imfinzi® and Lynparza® were (then) under review in Japan and several other countries.