AstraZeneca Gets CDSCO Approval for Durvalumab-Based Therapy

AstraZeneca Pharma India has announced CDSCO approval for Durvalumab in combination with FLOT chemotherapy, marking the first and only perioperative immunotherapy approach for adult patients with resectable gastric or gastroesophageal junction adenocarcinoma.

The Durvalumab approval decision-making relies on good phase III MATTERHORN study outcomes and introduces a novel survival-oriented alternative to the patients in their early, possibly curable disease stage.

With this approval, Durvalumab may be incorporated into FLOT chemotherapy in the neoadjuvant and adjuvant treatment and then as single-agent Durvalumab after surgery. It is a comprehensive perioperative approach that will reduce the risks of recurrence and enhance long-term outcomes, which is a significant gap in modern care of gastric cancer.

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In India, gastric cancer is still an issue of concern as it is ranked as seventh in the cancer incidence with the incidence of gastric cancer being more than 64,000 cases yearly and sixth in terms of cancer deaths. Almost fifty percent of the gastric cancer and gastroesophageal cancers are resected in the occurrence of cancer. Even with conventional perioperative FLOT chemotherapy, five-year survival remains under 50, and recurrence frequently happens within two years, which underscores the necessity to find superior treatment methods including Durvalumab.

Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India said, “We are transforming cancer care … demonstrates the power of science-led innovation at earlier stages, where the potential for cure is greatest.”

In the MATTERHORN study, the incidence of event free survival or death during the 4 years of the study was lower by 28% when Durvalumab was added to perioperative FLOT as compared to FLOT. A relative risk of death was also reduced by 21% as revealed by the study. This combination was acceptable, and there were no new safety issues.