FDA to fast-track review of BMS' CAR-T, ahead of shareholder deadline

Speculators who bought into a risky three-drug bet are still on track for a payout following Celgene's merger with Bristol-Myers Squibb, after the FDA agreed to fast-track its review of a new CAR-T drug nicknamed ‘liso-cel’.

The FDA has granted a faster six-month Priority Review for the drug for relapsed or refractory large B-cell lymphoma after at least two lines of therapy, and is due to make a decision before August 17, 2020.

That’s well ahead of the deadline of 31 December this year that forms part of a risky triple bet given to Celgene shareholders as a sweetener following the $74 billion merger in November.

For Celgene shareholders, or those who have bought the publicly traded “Contingent Value Right” (CVR), two other drugs must also get approved in time for certain deadlines.

The MS drug ozanimod must also be approved by 31st December and the CAR-T bb2121 must get the nod by March 31, 2021, with each CVR paying out $9 if all three goals are met.

Liso-cel was developed by Celgene’s subsidiary, Juno, under the codename of JCAR-017.

The FDA filing is based on results from the TRANSCEND NHL 001 trial evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.

If approved, liso-cel will be competing against the two other CAR-T therapies approved by the FDA – Novartis’ Kymriah, and Gilead’s Yescarta, which are both okayed for use in certain types of B-cell lymphoma.

The FDA reserves its faster reviews for drugs that could be an improvement over existing therapies for serious conditions.

Stanley Frankel, senior vice president of Cellular Therapy Development at BMS, said: “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.

“This is an important step as we work to improve treatment for these patients in need.”