CDSCO Clears Durvalumab with FLOT as New Perioperative Standard for Gastric Cancer Patients in India | iPharmaCenter
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- 5 hours ago
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CDSCO Clears Durvalumab
AstraZeneca received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for the use of durvalumab in combination with FLOT chemotherapy, a regimen including fluorouracil, leucovorin, oxaliplatin, and docetaxel, as a perioperative treatment for adults with resectable gastric and gastroesophageal junction (GEJ) adenocarcinoma.
This marks the first and only immunotherapy-based perioperative regimen to demonstrate a survival advantage in these patients.
The approval is supported by findings from the Phase III MATTERHORN trial, which evaluated the benefit of integrating durvalumab with FLOT chemotherapy before and after surgery, followed by single-agent durvalumab maintenance therapy. This comprehensive perioperative strategy is designed to increase cure potential, minimize disease recurrence, and improve long-term survival outcomes.
Addressing a Significant Unmet Need in India
Gastric cancer continues to be a major public health issue in India, ranking seventh among the most common malignancies with over 64,000 new diagnoses annually. It also stands as the sixth leading cause of cancer-related mortality.
About half of the patients present with disease that is still surgically resectable, where perioperative chemotherapy forms the current standard approach. However, despite treatment with FLOT, five-year survival remains below 50%, and recurrence within two years post-surgery is frequent, indicating the need for improved therapeutic options.
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MATTERHORN Trial Results
Data from the MATTERHORN study revealed that adding durvalumab to perioperative FLOT therapy led to a 28% reduction in the risk of disease progression or death compared to FLOT plus placebo. The trial also demonstrated a 21% relative reduction in mortality risk, confirming a significant overall survival benefit.
The combination regimen was generally well-tolerated, showing safety outcomes consistent with previously known profiles of durvalumab and FLOT, with no unexpected adverse events.
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About Durvalumab
Durvalumab is a human monoclonal antibody of the IgG1 kappa subtype that inhibits the interaction between PD-L1 and its binding partners PD-1 and CD80, leading to restoration and activation of T-cell–mediated antitumor responses.
By integrating immunotherapy into the perioperative management of gastric and GEJ cancers, AstraZeneca aims to elevate the treatment paradigm and provide patients with better chances of prolonged survival and reduced recurrence.
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