- Bristol Myers Squibb and Bluebird bio said they have submitted the cancer cell therapy ide-cel, or idecabtagene vicleucel, to the Food and Drug Administration for approval, putting it potentially on a schedule for approval by the end of 2020.
- Approval of another cancer cell therapy called liso-cel, or lisocabtagene maraleucel, by Dec. 31 and ide-cel by March 31, 2021 will trigger an extra $9 a share payout to investors in the former Celgene, which acquired the former drug when it bought Juno Therapeutics and in-licensed the latter from Bluebird.
- The path to that payout, a component of Bristol Myers’ $74 billion acquisition of Celgene last year, stayed on track with the FDA approval last week of multiple sclerosis drug Zeposia, which also had a Dec. 31 deadline.
The FDA has granted multiple myeloma treatment ide-cel “breakthrough therapy designation,” and one of the accompanying advantages with that tag is a six-month approval timeline. Based on today’s submission, the FDA’s deadline should fall sometime in the final three months of 2020, assuming no setbacks.
With liso-cel’s application also securing a speedy review and Zeposia already approved, Bristol Myers now has a good chance to beat all of the deadlines tied to its $9-per-share payout to Celgene shareholders. Should the payout be issued, it would add another $6 billion to Celgene's price tag.
Liso-cel and ide-cel are what's known as CAR-T cell therapies, or chimeric antigen receptor T cell therapies. They work by re-engineer patients' own immune systems to attack tumor cells. Ide-cel is the first CAR-T submitted to the FDA as a proposed treatment for multiple myeloma, and it's also one of several CAR-T and antibody-based therapies in development that target BCMA, a protein on tumor cells in multiple myeloma patients.
If approved, ide-cel would be prescribed to multiple myeloma patients who have failed at least three separate treatments. The FDA submission was based on the KarMMA study, which the company has said succeeded in putting patients in remission, although it has yet to release detailed data.
There may be a delay in gathering more data as well. Due to the coronavirus outbreak, Bristol Myers has suspended screening, enrollment and apheresis — the method of withdrawing patient plasma for processing of immune cells — in ongoing clinical trials of both ide-cel and liso-cel.
Should it get to market, ide-cel will almost certainly face some competitive challenges. GlaxoSmithKline, for instance, in December filed for approval a BCMA-targeting antibody drug conjugate called belantamab mafodotin.
Compared with ide-cel, which requires patients to have their immune cells withdrawn and re-engineered outside the body before being re-infused just once, belantamab mafodotin would offer a simpler treatment approach of repeat infusions.
Johnson & Johnson, meanwhile, has a BCMA-targeting CAR-T called JNJ-4528, which could have enough data to ask the FDA for approval later this year. Poseida Therapeutics is in the mix as well.
Data from 35 BCMA-targeting programs were presented at December’s meeting of the American Society of Hematology, according to a tally by the investment bank Bernstein, suggesting that competition could heat up even further.