AstraZeneca chalks up European approval for Imfinzi in locally advanced, unresectable lung cancer
pharmafile | September 25, 2018 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, Cancer, MedImmune, NSCLC, lung cancer, pharma
AstraZeneca and its global biologics R&D arm MedImmune have announced the approval by the European Commission of Imfinzi (durvalumab) as a monotherapy for locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed after receiving platinum-based chemotherapy and radiation therapy (CRT).
The decision was based on Phase 3 data from the PACIFIC trial, and follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) back in July. Throughout the trial, Imfinzi demonstrated “compelling overall survival benefit and progression-free survival of more than 11 months”.
“Lung cancer is the leading cause of cancer-related death in Europe and approximately a third of European patients with NSCLC present with locally-advanced disease,” said Dr Luis Paz-Ares, co-principal investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre in Madrid. “For decades, the standard of care for these patients has been chemotherapy and radiation therapy followed by active surveillance, after which the majority of patients progress to advanced disease. Imfinzi has demonstrated a compelling survival benefit for these patients in this area of significant unmet need.”
Dave Fredrickson, Executive Vice President, Head of AstraZeneca’s Oncology Business, added: “Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease.”
According to AstraZeneca, Imfinzi is the first and only treatment approved for unresectable, Stage 3 NSCLC in the US, Canada, Japan, Switzerland, India and Brazil.
Matt Fellows
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