The U.S. Food and Drug Administration accepted a supplemental new drug application for BeiGene’s Bruton’s kinase inhibitor Brukinsa (zanabrutinib) as a potential treatment for Waldenström macroglobulinemia, a type of non-Hodgkin lymphoma.
Bayer AG struck a $2 billion deal to resolve future legal claims that the German company widely used weedkiller Roundup causes cancer.
The U.S. Food and Drug Administration approved Pfizer’s Xalkori (crizotinib) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is anaplastic lymphoma kinase-positive.
The American Society of Hematology (ASH) Annual Meeting & Exposition began December 5 with numerous presentations, abstracts and posters.
The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
The U.S. Food and Drug Administration granted accelerated approval to Gilead Company Kite’s Tecartus (brexucabtagene autoleucel, formerly KTE-X19) as the first approved chimeric antigen receptor T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Cambridge, Massachusetts-based Unum Therapeutics announced a restructuring in order to shift assets toward the company’s preclinical program, BOXR1030, for solid tumors.
A late-stage trial failed to show that BeiGene Ltd.’s cancer treatment Brukinsa was superior to Imbruvica, a rival drug from Johnson & Johnson and AbbVie Inc., for treating WM.
Bristol-Myers Squibb announced positive results for the CAR-T therapy lisocabtagene maraleucel (liso-cel) in three studies at the American Society of Hematology Annual Meeting.
The FDA approved BeiGene Ltd.’s lymphoma treatment Brukinsa, validating the China-based drugmaker’s strategy of largely using data from clinical trials held outside the U.S. to file for approval.