FDA approves crucial new indication for Imfinzi

The US Food and Drug Administration on Friday approved immuno-oncology drug Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

This is an important development for Anglo-Swedish pharma major AstraZeneca (LSE: AZN), whose share gained 2.6% to 4,873 pence at peak on Friday, as it opens up a multibillion-dollar market for a drug that has so far lagged behind competitors.

The poor MYSTIC trial results last year for Imfinzi in combination with its CTLA-4 tremelimumab (seeing a 16% share price drop), dented AstraZeneca's ambitions for the drug, although it later released full data from two successful lung cancer drug trials.