Australians with mantle cell lymphoma (MCL) will now have subsidized access to Beigene Ltd.’s BTK inhibitor, Brukinsa (zanubrutinib), as of March 1, marking the company’s first drug to be listed on Australia’s Prescription Benefits Scheme (PBS).
Beigene Ltd. unveiled positive interim results from its Alpine phase III trial comparing its small-molecule BTK inhibitor, Brukinsa (zanubrutinib), to Abbvie Inc.’s Imbruvica (ibrutinib), lending validity to one of the company’s most important development programs.
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial.
Beigene Ltd.’s selective inhibitor, Brukinsa (zanubrutinib), made up for a 2019 miss in a head-to-head study against Johnson & Johnson and Abbvie Inc.’s Imbruvica (ibrutinib) with positive new data from a phase III trial in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
Chinese biotech firm Beigene Ltd. said its second-generation BTK inhibitor, Brukinsa (zanubrutinib), has won approval in China for two indications, entering a market dominated by Imbruvica (ibrutinib, Johnson & Johnson/Abbvie Inc.). The NDA approval came eight months after Brukinsa’s clearance in the U.S.
BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance. Beigene said Brukinsa is the only FDA-approved BTK inhibitor shown to deliver 100% median occupancy in peripheral blood cells. It is also the only BTK inhibitor that can be taken once or twice daily. Brukinsa is expected to be launched in the U.S. in the coming weeks.
BEIJING Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance.