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June 2, 2022

Around the nation: FDA grants expanded approval for CAR-T therapy

Daily Briefing

    FDA granted expanded approval for CAR-T therapy for cancer patients with relapsed or refractory follicular lymphoma, in today's bite-sized hospital and health industry news from Arizona, Maryland, and Pennsylvania.

    • Arizona/Pennsylvania: A new study published June 1 in Lancet Digital Health found that a machine learning algorithm could reliably predict the three-month risk of opioid overdose. The study was funded by NIH, the National Institute on Drug Abuse, and the National Institute on Aging. For the study, researchers analyzed data from almost 14,000 Medicaid recipients in Pennsylvania and Arizona who had opioid overdoses between 2013 and 2018. The researchers used a tool with 284 potential predictors from pharmaceutical and health care claims data. According to the researchers from the University of Florida, University of Pittsburgh, University of Arizona, University of Utah, and Carnegie Mellon University, future research should focus on other state Medicaid programs and different areas of the country, including the Midwest and South. (Bruce, Becker's Hospital Review, 5/31)
    • Maryland: FDA on Tuesday granted expanded approval for CAR-T therapy to treat cancer patients with relapsed or refractory follicular lymphoma after they have received two or more lines of systemic therapy. The accelerated approval was granted for tisagenlecleucel—the only CAR-T cell therapy currently approved for both adult and pediatric cancer patients. "Being able to expand the reach of this personalized therapy to patients with follicular lymphoma is an exciting milestone for our team, our patients, and their families," said Stephen Schuster, director of the Richard Berman Family Center for Innovation in CLL and Lymphomas in the University of Pennsylvania's Perelman School of Medicine and the Abramson Cancer Center. "For too long, we have had little to offer our patients when they relapse, and with today's news, we can offer them new hope." (Gleeson, Becker's Hospital Review, 5/31)
    • Pennsylvania: Universal Health Services (UHS) on Saturday announced that it would assume full ownership of George Washington University Hospital (GWUH). For almost 25 years, GWUH was owned and operated by a UHS subsidiary and George Washington University (GWU). Under the former arrangement, UHS held an 80% stake and GWU held a 20% stake. "We are confident that through this restructured partnership, we will be able to mutually meet our quality-of-care goals while also growing our integrated delivery model and further expanding access to care," said Marc Miller, president and CEO of UHS. Notably, the former partnership helped GWUH become a Level I trauma center and a comprehensive stroke center. "The revised arrangement not only resets the decades-long partnership to create a stronger, more sustainable foundation for both organizations to step into the future, but it also reignites a shared enthusiasm to expand and enhance excellent care for our patients and the citizens of our region," said GWU President Mark Wrighton. (Berryman, Modern Healthcare, 5/31)

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