The Food and Drug Administration is giving a priority review to lisocabtagene maraleucel (liso-cel), a CAR-T (chimeric antigen receptor T-cell) therapy from Bristol-Myers Squibb (NYSE:BMY). The agency plans to make a decision on the marketing application by Aug. 17, four months earlier than it would have under the standard review process.
Like other CAR-T therapies being developed by various biotech companies, liso-cel involves taking immune cells from the patient, manipulating them so they target lymphoma cells that express a specific protein -- in this case, one called CD19 -- and then putting them back into the patient, where they attack the blood cancer.
Bristol-Myers Squibb acquired liso-cel through its purchase of Celgene, which in turn had gained it via its purchase of Juno Therapeutics. Liso-cel would be the first treatment developed by Juno to gain FDA approval, but the BMS subsidiary has a full pipeline of CAR-T therapies, as well as therapies incorporating a related technique that uses the T-cell receptor to target immune cells to tumor cells.
The marketing application is based on the Transcend NHL 001 clinical trial, in which 73% of the 256 treated patients responded to liso-cel, including 53% who had a complete response. Patients lived for a median of 21.1 months, quite an accomplishment considering that multiple other therapies had failed the patients in the study.
Former Celgene shareholders will want to keep a close eye on the approval since it's part of a contingent value right (CVR) that could result in an additional $9 payment for each CVR held if liso-cel and two other drugs are approved.
If it's approved, liso-cel will join two CAR-T treatments that have already gained FDA approval to treat types of lymphoma: Novartis' Kymriah and Gilead Sciences' Yescarta.