Cell therapy offers a treatment option for some advanced blood cancers, but the manufacturing process is lengthy and complex. The biopharmaceutical industry is working on various technologies that could make manufacturing faster and more efficient, or perhaps supplant the current process altogether.
The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
The company said Friday that it had submitted for approval of Yescarta in follicular and marginal zone lymphoma, based on data from the ZUMA-5 study that were presented at the 2020 ASCO meeting in May.
Data on multiple CAR-Ts presented at the recent ASCO meeting have raised the prospect of outpatient use of the therapies, which is favorable for reimbursement as well as for patients. But experts pointed to significant infrastructure challenges that centers face.
The company is seeking approval for Yescarta in follicular and marginal zone lymphomas. While it has a clear efficacy advantage over existing therapy options, experts said whether to use it in their place will entail complicated conversations with patients.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
A federal jury in California found that Kite Pharma - now part of Gilead Sciences - violated a patent from Memorial Sloan Kettering Cancer Center and licensed to BMS' Juno Therapeutics in developing the CAR-T therapy Yescarta, approved in 2017.
The Medicare coverage decision, issued Wednesday evening after a nearly three-month delay, removes several requirements that some had feared would limit access to the cell therapies, while also allowing for some off-label use.
In a statement, the agency said that a decision on whether to have Medicare cover the cell therapies would not be issued Friday, but would be forthcoming.
A spokesperson for the company noted that patients in the Phase II L-MIND trial of the CD19-targeting drug tafasitamab would be too old and frail to be candidates for CAR-T therapies.
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The company, part of Gilead Sciences since 2017, had placed an early emphasis on ensuring manufacturing capacity could meet demand - a key consideration in cell and gene therapy.
The agency also proposed increasing the maximum new technology add-on payment from 50 percent to 65 percent for fiscal year 2020.
Allogeneic CAR-Ts could serve an important niche - particularly for patients who can't receive autologous CAR-Ts - but the earliness of the data makes conclusions tough to draw.
The lack of an overarching CMS reimbursement policy on CAR T-Cell therapy has meant that coverage decisions have generally landed on the desk of local Medicare Administrative Contractors.
Along with Boston Scientific's Watchman in the technology category, Novartis and Gilead's Kite shared the biotechnology award for CAR-T therapy, while Celgene/Agios's Idhifa won the pharmaceutical prize.