Science & TechnologyImportant2026-01-31

CDSCO Approves Durvalumab Immunotherapy for Gastric Cancer

In News

What Happened

On January 31, 2026, the Central Drugs Standard Control Organisation (CDSCO) approved AstraZeneca's Durvalumab in combination with FLOT chemotherapy. It is India's first perioperative immunotherapy approach approved for treating adult patients with resectable gastric and gastroesophageal junction adenocarcinoma.

Why It Matters

Gastric cancer is the seventh most common cancer in India, with over 64,000 new cases annually and a 5-year survival rate below 50 percent under standard care. This approval brings immunotherapy earlier in the treatment pathway, offering a 28 percent reduction in disease recurrence risk and significantly improving long-term survival.

Background

History & Context

Around half of gastric cancers are diagnosed at a resectable stage, where surgery and perioperative chemotherapy (FLOT) have traditionally been the standard of care. Despite this, recurrence remained high within two years of surgery. Based on the Phase III MATTERHORN global study, which demonstrated significant overall survival benefits, the CDSCO granted regulatory approval for this new combined regimen in early 2026.

What Changed

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Treatment Protocol: BEFORE, the standard was surgery combined only with perioperative FLOT chemotherapy. NOW, Durvalumab is added to FLOT in both neoadjuvant (before surgery) and adjuvant (after surgery) settings, followed by single-agent Durvalumab maintenance.
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Survival Outcomes: BEFORE, the five-year survival rate for resectable gastric cancer remained below 50 percent despite FLOT treatment. NOW, clinical trials show a 28 percent reduction in the risk of event-free survival events or death when Durvalumab is added.
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Mechanism of Action: BEFORE, standard perioperative care relied on cytotoxic chemotherapy, which non-specifically kills rapidly dividing cells. NOW, patients receive a targeted monoclonal antibody (Durvalumab) that blocks the PD-L1 protein, preventing tumor cells from evading the T-cell immune response.

Prelims Angle

NCERT Connection

This directly applies to the concepts of Cancer and Immunology in Class 12 Biology Chapter 8 (Human Health and Disease). While NCERT introduces biological response modifiers like alpha-interferons that activate the immune system to destroy tumors, Durvalumab is a highly advanced application of this concept called a checkpoint inhibitor, which specifically prevents cancer cells from evading T-cells.

Practice Questions

Q1

Correct Statement(s)

Which of the following statements is/are correct regarding the recent CDSCO approval of Durvalumab? 1. Durvalumab is a monoclonal antibody that acts as a checkpoint inhibitor by blocking the PD-L1 protein. 2. It was approved as India's first perioperative immunotherapy approach specifically for non-small cell lung cancer.

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