AstraZeneca Pharma India Limited has been granted permission by the Central Drugs Standard Control Organisation (CDSCO) to market Durvalumab solution for infusion for an additional indication. This approval allows the use of Durvalumab in combination with carboplatin and paclitaxel for the first-line treatment of adults with primary advanced or recurrent endometrial cancer.
The company’s latest stock exchange filing revealed that Durvalumab, when used in combination with specific drugs, is now indicated for the treatment of endometrial cancer patients who require systemic therapy. This approval also includes maintenance treatment with Durvalumab as monotherapy for endometrial cancer that is mismatch repair deficient (dMMR).
AstraZeneca Pharma India Limited confirmed that they have received the necessary permission to import and distribute Durvalumab Solution for Infusion in India for the specified additional indication. This regulatory clearance sets the stage for the marketing of Durvalumab Solution, subject to any related statutory approvals that may be required.
Earlier, the company had announced CDSCO’s approval for Durvalumab in combination with FLOT chemotherapy as the first perioperative immunotherapy approach for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). This approval, based on the ‘phase III MATTERHORN’ study results, aims to enhance long-term outcomes by reducing recurrence risk through a comprehensive perioperative approach.
