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FDA gives priority review for AstraZeneca’s Imfinzi

Published on 29/11/19 at 12:40pm

The FDA has granted a priority review of AstraZeneca’s cancer treatment drug Imfinzi (durvalumab) for treatment of patients with untreated small cell lung cancer (SCLC), according to the company.

The move comes after positive results of their Phase 3 CASPIAN trial. The results, recently released in The Lancet journal, showed that there was significant and clinically meaningful improvement in survival rates from the drug.

SCLC is an aggressive, fast-growing form of lung cancer that recurs and progresses rapidly despite initial response to platinum-based chemotherapy.

AstraZeneca’s Imfinzi is already approved for unresectable stage three non-small cell lung cancer (NSCLC) in 54 countries. The drug boosts the body’s immune system to fight cancer cells in people with NSCLC, with an existing approval for use in situations where tumours have only spread in the chest.

The FDA had previously approved Roche’s immunotherapy Tecentriq for the treatment of SCLC, while Bristol-Myers Squibb’s Opdivo is also approved in cases where patients fail at least two other treatments.

AstraZeneca said the FDA’s final decision on whether to approve Imfinzi is expected during the first quarter of 2020.

Conor Kavanagh


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