AstraZeneca’s cancer drug Imfinzi has won a key recommendation from a European Medicines Agency (EMA) panel less than six months after the first global approvals in Western markets.
EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Imfinzi, an immunotherapy drug already boosting sales for the British drugmaker, for use in lung cancer patients with inoperable disease that had advanced locally but not spread widely around the body.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months.
The U.S. Food and Drug Administration (FDA) in February 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.
Japan also approved the drug earlier this month.
The latest green light – which had been expected after 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.
Globally, about 30 percent of patients with NSCLC present with stage III disease. These individuals typically receive a combination of chemotherapy and radiotherapy, but only around 15 percent of them are still alive after five years.
Imfinzi, chemically known as durvalumab, belongs to a new class of immuno-oncology drugs that block a mechanism tumors use to evade detection from the immune system.
AstraZeneca’s drug already had approval for treating certain patients with bladder cancer. However, this market is relatively small.
The really big opportunity for all companies seeking to exploit the power of modern immuno-oncology drugs is lung cancer, since it is the leading cause of cancer deaths.
Bristol-Myers Squibb, Roche, and Merck all have approved products for treating certain patients with advanced lung cancer – but AstraZeneca is now in a position to carve out a niche in treating earlier stage III patients.