FDA grants priority review to AstraZeneca's Imfinzi filing in small-cell lung cancer

AstraZeneca announced Friday that the FDA granted priority review to a filing seeking expanded approval of the PD-L1 inhibitor Imfinzi (durvalumab) to include the treatment of patients with previously untreated extensive-stage small-cell lung cancer (SCLC). The company noted that the agency's target action date for the application is in the first quarter of 2020.

The submission is based on findings from the Phase III CASPIAN trial, which showed that Imfinzi in combination with standard-of-care chemotherapy demonstrated a significant and clinically meaningful improvement in overall survival (OS) versus standard-of-care chemotherapy alone. Results indicated that Imfinzi reduced the risk of death by 27%, with median OS of 13 months for Imfinzi plus chemotherapy, compared to 10.3 months for standard-of-care chemotherapy.

Earlier this year, Roche's Tecentriq (atezolizumab) gained FDA approval for use in combination with chemotherapy for the first-line treatment of adults with extensive-stage SCLC, making the PD-L1 inhibitor the first cancer immunotherapy authorised in this indication. The drug has also been cleared for this use in Europe.

Imfinzi, which generated sales of $412 million in the third quarter, is approved in the curative-intent setting of unresectable, Stage III non-small-cell lung cancer after chemoradiation therapy in 54 countries, including the US, Japan and the EU, as well as for previously treated patients with advanced bladder cancer in 11 countries, including the US.

For related analysis, see ViewPoints: Imfinzi holds par with Tecentriq in SCLC with Keytruda waiting in the wings, and KOL Views Results: Imfinzi has tough job to pip Tecentriq in SCLC and victory may prove pyrrhic, says leading oncologist.

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