FDA grants priority review to Bristol-Myers Squibb's filing for liso-cel in B-cell lymphoma

Bristol-Myers Squibb announced Thursday that the FDA granted priority review to a filing seeking approval of lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The company gained the autologous anti-CD19 CAR T-cell immunotherapy as part of last year's $74-billion purchase of Celgene.

Stanley Frankel, senior vice president at Bristol-Myers Squibb's cellular therapy development unit, remarked "based on the TRANSCEND NHL 001 data, liso-cel has the potential to expand treatment options for those affected by this aggressive blood cancer who did not respond to initial therapies or whose disease has relapsed." Results presented in December at the American Society of Hematology (ASH) annual meeting showed that in the pivotal Phase I study, the overall response rate associated with liso-cel was 73%, with 53% of subjects achieving a complete response.

As part of the purchase of Celgene, former shareholders of the company received a contingent value right linked to the achievement of future regulatory milestones, with one of these being FDA approval of liso-cel by December 31 this year. Bristol-Myers Squibb noted Thursday that the regulator has assigned a target review date of August 17 for the marketing application.

Liso-cel, previously known as JCAR017, has been granted breakthrough therapy and regenerative medicine advanced therapy designations by the FDA for relapsed or refractory aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma.

For related analysis, see ViewPoints: ASH19- Bristol-Myers Squibb nears its CAR-T reckoning, and KOL Views Results: Leading oncologist is optimistic about liso-cel’s outpatient potential.

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