The U.S. FDA is to temper the alert it put out in November 2023 pointing to a potential risk of CAR T therapies causing de novo malignancies. “There was this issue of possible safety concerns with T-cell lymphomas, with these CAR T cells. I think this year, we are feeling reassured in this regard,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), told the Alliance for Regenerative Medicine briefing at the J. P. Morgan Healthcare Conference on Jan. 13.
As South Korea awaits potential changes to drug pricing policies for generics and novel ultra-expensive therapies like Novartis AG’s Kymriah (tisagenclecleucel), the domestic pharmaceutical industry is proactively voicing concerns about some policies that could do more harm than good.
Reports of T-cell malignancies, including lymphoma, have the U.S. FDA investigating the risks for patients who received certain autologous CAR T-cell immunotherapies.
Novartis AG’s CAR T therapy, Kymriah (tisagenlecleucel), is heading for a third indication after the Basel, Switzerland-based pharma announced supportive results from a pivotal phase II trial, lining it up to compete with Gilead Sciences Inc.’s rival, Yescarta.
Prescient Therapeutics Pty Ltd. is poised to develop next-generation CAR T therapies after signing a deal with the University of Pennsylvania for a universal immune receptor technology platform.
PERTH, Australia – Melbourne-based Prescient Therapeutics Pty Ltd. is poised to develop next-generation CAR T therapies after signing an exclusive global licensing deal with the University of Pennsylvania for a universal immune receptor technology platform.
Innovation is being rewarded under Medicare’s proposed fiscal 2021 Inpatient Prospective Payment System (IPPS) that was unveiled Monday. For starters, the Centers for Medicare and Medicaid Services (CMS) is proposing a new Medicare-severity-diagnosis related group (MS-DRG) specifically for CAR T therapies.
