The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.
The companies' resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.
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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 FDA requested supplemental documentation related to chemistry, manufacturing and controls rather than new clinical or preclinical data. The companies plan to resubmit the application and request a priority review by the end of July.
BMS bought out its milestone and royalty obligations for ex-U.S. markets for idecabtagene vicleucel, or ide-cel, which is currently undergoing FDA review. The companies will continue to share profits and losses in the U.S.
The submission of an application for idecabtagene vicleucel comes shortly after Bristol-Myers Squibb filed for approval of another CAR-T, lisocabtagene maraleucel, in an aggressive form of lymphoma. The FDA is expected to rule on that CAR-T by February.
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A Cannacord Genuity analyst pointed to BMS' large pipeline of BCMA-targeting therapies and advanced data, particularly for its CAR-T. However, GlaxoSmithKline has also asserted its anti-BCMA drug could be first past the FDA finish line. But does it matter?
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.
In data from several clinical trials released Friday and during the weekend, cell and other therapies for multiple myeloma targeting the antigen BCMA showed strong response rates.
An analyst wrote that it is unlikely bluebird would provide full data from its registration-directed study of the CAR-T bb2121 by year end, which is more likely to come early next year.
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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.