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.
Bristol-Myers Squibb said the FDA had accepted and granted priority review to its application for lisocabtagene maraleucel in diffuse large B-cell lymphoma. The agency will decide whether to approve it by Aug. 17. Two other CAR-Ts are already approved for DLBCL.
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In a breakout session at the J.P. Morgan Healthcare Conference Monday, the company's executive team was optimistic about manufacturing and reimbursement for its CAR-Ts to treat lymphoma and multiple myeloma.
Celgene plans to file for approval of bb2121 (idecabtagene vicleucel) in myeloma in the first half of 2020, and lisocabtagene maraleucel in lymphoma in the fourth quarter of this year.
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.