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Drugs & TargetsFree

FDA accepts Celyad IND application for CYAD-101, a non-gene edited allogeneic CAR-T candidate

Celyad said FDA has accepted the company's Investigational New Drug application for CYAD-101, the first non-gene edited allogeneic clinical program. FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.
Clinical RoundupFree

Takeda’s Alunbrig meets PFS primary endpoint

The global, randomized, phase III ALTA-1L trial met its primary endpoint at the first pre-specified interim analysis, with Alunbrig (brigatinib) demonstrating a statistically significant improvement in progression-free survival compared to crizotinib in adults with anaplastic lymphoma kinase-positive locally advanced or metastatic non-small cell lung cancer who had not received a prior ALK inhibitor.