Yescarta
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As Cell Therapy Gains Ground, Efforts Emerge to Improve CAR T-Manufacturing
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.
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BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy
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.
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Payer’s Place: Dawn Maroney
Dawn Maroney, President, Markets of Alignment Health and CEO of Alignment Health Plan, to discuss how they are using technology to provide better service and care to consumers.
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MD Anderson researchers find mechanisms behind CAR-T cells’ efficacy, toxicity
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
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Gilead’s Kite submits FDA approval application for CAR-T in slow-growing lymphomas
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.
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Outpatient use of CAR-Ts is enticing, but it comes with significant challenges too
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.
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Gilead CAR-T’s indolent lymphoma data impresses at ASCO. How to position it is another question
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.
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Jury awards BMS subsidiary $752M in CAR-T patent infringement suit
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.
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CMS goes for liberal approach in Medicare CAR-T coverage
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.
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CMS delays national coverage determination for CAR-T therapies
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.
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Applying Remote Patient Monitoring to Surgery Prep and Recovery, Oncology and Women’s Health
Join us to learn about the latest trends in remote monitoring and how to extend its benefits beyond chronic conditions to more patients – all while using fewer staff resources.
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MorphoSys posts positive data for lymphoma drug, but will it compete with CAR-Ts?
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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Kite Pharma to expand manufacturing capacity with Maryland plant
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.
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CMS proposes continuing new technology add-on payments for CAR-T cell therapies next year
The agency also proposed increasing the maximum new technology add-on payment from 50 percent to 65 percent for fiscal year 2020.
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‘Off-the-shelf’ CAR-Ts have an important role to play – but are they ready for prime time?
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.
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Medicare could start covering CAR T-Cell therapy under new CMS proposal
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.
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Devices & Diagnostics, BioPharma, Pharma
Novartis, Gilead, Celgene/Agios blood cancer treatments sweep Prix Galien awards
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.
Promoted
Payer’s Place: Dr. Anil Singh
Dr. Anil Singh shares his insights into the strategies employed by the organization to identify the most effective digital solutions for their members.
Promoted
Discover the Next-Gen Platform for Integrated Collaborative Care
Beyond EHRs and digital front doors, reducing the gaps in patient care journeys.
