The Phase III study showed that BeiGene's Brukinsa outperformed AbbVie and J&J's Imbruvica on safety. An analyst wrote that FDA approval on that basis is unlikely, but off-label prescribing is possible. Brukinsa won approval for another blood cancer last month.
ArQule's lead product candidate is a BTK inhibitor, ARQ-531, designed for heavily pretreated patients with leukemias and lymphomas, particularly those whose disease has become resistant to marketed BTK therapies. Phase I data on the drug were also presented Monday.
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