BeiGene’s Leukemia Drug FDA Decision Delayed

June 13, 2022

In a temporary win for AbbVie and Johnson & Johnson’s chronic lymphocytic leukemia (CLL) drug Imbruvica, the FDA has extended the decision timeline for Beigen’s competing drug Brukinsa. The agency will review new data from the company’s Alpine phase 3 trial that compared its drug against Imbruvica in patients who’ve already undergone some form of treatment for CLL.

According to Angus Liu, “For the Alpine study, BeiGene originally reported an interim analysis last year, showing that by an independent data review committee, Brukinsa narrowly missed statistical significance in terms of better tumor shrinkage than Imbruvica. By investigator calculation, which was Alpine’s primary endpoint, Brukinsa’s advantage had already met the statistical bar at interim.”

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(Source: Fierce Pharma, June 13th, 2022)

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