Emphasizing April’s vote of concern about the safety of PI3K inhibitors, the U.S. FDA’s Oncologic Drugs Advisory Committee said privately held Secura Bio Inc.’s Copiktra (duvelisib) is more of a hindrance than a help. The adcom voted 8-4 on Sept. 23 that it sees a detriment in overall survival (OS) and some other safety issues that were revealed in newly updated data for the cancer treatment. Approved in 2018 for treating adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, Secura argued that its data continue to show a statistically significant and clinically meaningful benefit in OS and also in progression-free survival.
Nurix Therapeutics Inc. has started its first phase Ib expansion cohort for treating chronic lymphocytic leukemia with NX-2127 but it is facing the headwind of a drop in share price. Shares (NASDAQ:NRIX) of the San Francisco-based company closed 22.7% lower at $7.88 each on May 26. Share prices in the past 12 months have drifted lower since their crest of $26.69 each on Sept. 9, 2021.
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The dosing by Vincerx Pharma Inc., in mid-December of last year, of the first patient in the phase I study with VIP-152 marked the second experiment begun by the company in 2021, and added oomph to the already-growing renewal of interest in CDK9 as a therapeutic target.
Shares of TG Therapeutics Inc. fell 40% Jan. 27 after the firm disclosed in a U.S. SEC filing that the FDA had put a partial clinical hold on certain studies testing Ukoniq (umbralisib) and ublituximab, or the combination, for chronic lymphocytic leukemia and non-Hodgkin lymphoma.
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.
Johnson & Johnson’s Janssen Cilag Ltd. pharma unit has phase III data from its project combining the oral blood cancer drug Imbruvica (ibrutinib) with its blockbuster rival, Venclexta (venetoclax), in chronic lymphocytic leukemia (CLL), which could give it an edge over competitors in the space.
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.
