The approval was based on a trial involving 713 patients
AstraZeneca’s immunotherapy drug Imfinzi has won crucial approval from US regulators for use in lung cancer, opening up a multibillion-dollar market for a medicine that has so far lagged behind competitors.
The US Food and Drug Administration (US FDA) said that it had granted approval for expanded use of Imfinzi to treat non-small cell lung cancer (NSCLC) patients with inoperable mid-stage disease that has not spread widely around the body.
The green light – which had been expected following positive clinical data last year – gives AstraZeneca a chance to intervene earlier in lung cancer, distinguishing it from rivals that have approval for tackling advanced or metastatic disease.
Analysts believe using Imfinzi in so-called stage III lung cancer, where cancer has only spread locally, opens up an annual sales opportunity worth around $2 billion. Importantly, AstraZeneca has a lead of two to three years over other drug companies in this particular area.
The approval was based on a trial involving 713 patients, showing patients survived on average 16.8 months without their disease worsening when given Imfinzi, against just 5.6 months for those on placebo.