Thread by @VincentRK

Breaking News: lde-cel (Abecma; idecabtagene vicleucel), approved by FDA for multiple myeloma.

This is the first CAR-T therapy for myeloma. Many patients have been waiting for this good news. @agarwalonc @BMS_Myeloma_US @bluebirdbio news.bms.com/news/corporate…

Here is the data that led to the FDA approval published in @NEJM

73% response rate; 33% CR rate; 26% MRD-
Median PFS 9 months

Congrats everyone. Nikhil Munshi, @ldandersonjr @ninashah33 @DMadduri @BerdejaJesus @SagarLonialMD @NoopurRajeMD @YiLinMDPhD nejm.org/doi/full/10.10…

Side effects: Milder in my experience than approved lymphoma CAR-Ts. Grade 3 or higher cytokine release syndrome (CRS) in 5% of patients. Grade 3 neurotoxic effects in 3%.

Overall well tolerated.

The FDA approval of ide-cel (Abecma) is for patients with relapsed or refractory multiple myeloma after 4 or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

I'm pleased with this approval. It is a big step forward in immunotherapy for myeloma.

I expect PFS to be longer in real world practice. I also expect that CAR-T therapy along with other immunotherapeutic approaches will move into more earlier stages of the disease over time.