Astrazeneca's Imfinzi receives EU recommendation from CHMP
Drugmaker AstraZeneca Plc said on Monday that its gastric and gastroesophageal junction cancer treatment, Imfinzi, has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use (CHMP).
If approved, Astrazeneca said Imfinzi, used in conjunction with standard-of-care FLOT chemotherapy, regimen would mark the first immunotherapy-based perioperative therapy available to patients in this setting in the EU.
CHMP, part of the European Medicines Agency, based its positive opinion on event-free survival and overall survival data from the MATTERHORN Phase III trial of Imfinzi, the final OS analysis of which showed that patients treated with the Imfinzi-based perioperative regimen saw a 22% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone.
Susan Galbraith, Astrazeneca's executive vice president of oncology haematology research and development, said: "Imfinzi plus FLOT demonstrated a durable, increasing long-term survival benefit in the MATTERHORN trial, with more than two-thirds of patients alive at three years. The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU."
Separetely, Astrazeneca said its shares had begun trading on the New York Stock Exchange for the first time, enabling more US investors to "participate in the company's strong growth".
Reporting by Iain Gilbert at Sharecast.com
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