The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
The U.S. Food and Drug Administration approved Takeda Pharmaceutical Company Limited’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
The U.S. Food and Drug Administration granted approval to Seattle Genetics Inc.’s Tukysa tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.
Daiichi Sankyo Europe GmbH informed Nektar Therapeutics that it was terminating a collaboration and licensing deal, which becomes effective Feb. 4, 2018. All rights and licenses that Daiichi acquired in the deal will revert to Nektar.
Patients taking Roche’s targeted lung cancer drug Alecensa have a far lower risk of their disease spreading in the brain than those on Pfizer’s Xalkori, new clinical trial data show.