AstraZeneca gets CDSCO approval for Durvalumab in gastric cancer treatment

New Delhi: AstraZeneca Pharma India on Wednesday said it has received approval from the national health regulator for Durvalumab in combination with chemotherapy for treatment of gastric or gastroesophageal junction cancer.

The Central Drugs Standard Control Organisation (CDSCO) has granted 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.

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 per cent, and recurrence rates are high within two years of surgery, underscoring the need for more effective peri-operative options.

"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," AstraZeneca Pharma India Country President and MD Praveen Rao Akkinepally said in a statement.

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.