26th Jul 2024 13:27
AstraZeneca PLC - Cambridge, England-based pharmaceutical firm - Says it is "committed to working closely" with the US Food & Drug Administration to bring an Imfinzi-based treatment to patients with resectable non-small cell lung cancer, following a review of a phase III trial by the Oncologic Drugs Advisory Committee, an advisory body for the FDA. Astra says the Aegean trial of Imfinzi, whose generic name is durvalumab, showed a "statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone".
Astra says the discussion with the ODAC noted that "while the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, this is an important potential regimen for patients." The company notes that the FDA isn't bound by the advisory body's recommendation.
Imfinzi already is approved in Switzerland and the UK for treating resectable lung cancer, based on the Aegean trial results.
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By Tom Waite, Alliance News editor
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