BAYRY Bayer Aktiengesellschaft (PK)

By Colin Kellaher

German drugs-to-crops giant Bayer is pulling Aliqopa from the U.S. after a confirmatory trial of the lymphoma drug missed its primary endpoint.

Bayer on Monday said it will work with the U.S. Food and Drug Administration on a voluntary withdrawal of Aliqopa, which won accelerated approval from the agency in 2017 for adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.

The FDA's accelerated green light was conditioned on a study confirming Aliqopa's clinical benefit, but Bayer on Monday said the addition of Aliqopa to standard immunochemotherapy regimens didn't meet the study's primary endpoint of progression-free survival benefit versus the standard immunochemotherapy.

Bayer said it is exploring access options for current Aliqopa patients who have experienced a favorable response to treatment, as well as those whose physician supports continuing treatment with Aliqopa and those for whom there may be no suitable alternative treatments available, but the company said no new patients should be prescribed the drug.

Bayer had previously withdrawn its application seeking European approval of Aliqopa.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 13, 2023 10:43 ET (15:43 GMT)

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