Over the weekend, at the American Academy of Dermatology annual meeting, Novartis revealed early Phase IIb data from 66 patients who had been treated with either 25 mg or 100 mg of remibrutinib, which was dosed twice-daily.
Tag Archive for: BTK inhibitor
Yesterday the agency ranted accelerated approval to BeiGene’s BTK inhibitor Brukinsa (zanubrutinib), when used in combination with Genentech’s Gazyva (obinutuzumab), to treat patients with relapsed or refractory follicular lymphoma who have undergone at least two lines of systemic therapy.
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
The FDA granted accelerated approval to Eli Lilly’s reversible BTK inhibitor Jaypirca (pirtobrutinib) for the treatment of chronic lymphocytic leukemia or small lymphocytic leukemia in adult patients who have undergone at least two prior lines of therapy, including another BTK inhibitor and a BCL-2 inhibitor.
Sanofi is the latest company to do some spring cleaning of its pipeline. Thursday morning, the pharma announced it will discontinue two acquired programs in its Q1 update.
Novartis said no signs of liver damage had been seen in trials testing its anti-inflammatory drug candidate remibrutinib so far, voicing cautious optimism that it could elude the side effects that have beset rival products in the same drug class.
California-based Gossamer Bio announced Monday that it is discontinuing the development of its lymphoma candidate GB5121 following two patient deaths in the Phase Ib/II STAR-CNS study.
In a head-to-head comparison trial, BeiGene’s Brukinsa (zanubrutinib) bested Janssen’s Imbruvica (ibrutinib) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL).
The agency’s decision came after researchers found cases of drug-induced liver injury in some patients.
