Source: Sharecast
AstraZeneca said the regimen covers neoadjuvant Imfinzi with chemotherapy ahead of surgery, followed by adjuvant Imfinzi with chemotherapy and then Imfinzi monotherapy.
The FTSE 100-listed firm stated approval from the Food and Drug Administration followed a Priority Review and was based on event‑free and overall survival data from its Phase III MATTERHORN trial.
Dave Fredrickson, executive vice president of AstraZeneca's oncology haematology business unit, said: "This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers, with Imfinzi plus FLOT delivering a durable survival benefit that increases over time.
"As the third US approval for a perioperative Imfinzi-based regimen, this milestone further validates the perioperative approach and underscores our focus on bringing novel treatments to early-stage cancers where cure is the goal."
Reporting by Iain Gilbert at Sharecast.com