New Delhi, Feb 10 AstraZeneca Pharma India Limited on Tuesday said it has received permission from the Central Drugs Standard Control Organisation (CDSCO) to sell and distribute Durvalumab solution for infusion used in cancer treatment for an additional indication.
In its latest stock exchange filing, the drug company said that through this approval, “Durvalumab in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with Durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR)”.
According to the filing, “This is to inform that AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import for sale and distribution of Durvalumab Solution for Infusion 120 mg/2.4 mL and 500 mg/10 mL (Brand Name: Imfinzi) for an additional indication,” said AstraZeneca Pharma India Ltd.
The receipt of this permission paves way for the marketing of Durvalumab Solution for “Infusion 120 mg/2.4 mL and 500 mg/10 mL (Imfinzi) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any,” the filing further said.
Earlier, AstraZeneca Pharma India had announced the CDSCO approval for Durvalumab in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) as the first and only perioperative immunotherapy approach for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC), showing survival benefit.
Based on the results from the ‘phase III MATTERHORN’ study, the approval allows the addition of Durvalumab to FLOT chemotherapy for patients in the neoadjuvant and adjuvant settings, followed by single agent durvalumab, reflecting a comprehensive perioperative approach aimed at reducing recurrence risk and improving long-term outcomes.
Gastric cancer remains a major health challenge in India, ranking as the seventh most common cancer with over 64,000 new cases diagnosed annually, and the sixth leading cause of cancer-related deaths.
Around half of gastric and gastroesophageal junction cancers are diagnosed at a resectable stage, where surgery combined with peri-operative chemotherapy is the standard of care. Despite treatment with FLOT, five-year survival remains below 50%, and recurrence rates are high within two years of surgery, underscoring the need for more effective peri-operative options.
“We are transforming cancer care in India. Patients with resectable gastric and gastroesophageal junction cancers face high recurrence risk. Backed by the MATTERHORN study, this approval brings immunotherapy earlier in the treatment pathway, significantly improving survival,” said Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited.
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