Re: Farmas USA
Kite Submits Investigational New Drug (IND) Application for KITE-585, Anti-BCMA CAR-T Therapy Candidate for Multiple Myeloma
to initiate a Phase 1, first-in-human trial of KITE-585, a CAR-T cell therapy engineered to target B-cell maturation antigen (BCMA) in patients with relapsed/refractory multiple myeloma.
http://www.businesswire.com/news/home/20170808005533/en/
FDA hands Kite Pharma a pass on axi-cel panel review — CAR-T ready to launch
“The FDA has informed us that they will not schedule an advisory committee meeting” for axi-cel. This follows an FDA inspection of its manufacturing facility and its research sites in the lead-up to an accelerated review.
Kite faces a November 29 deadline for its marketing decision from the FDA, but the company says it’s ready to start making the personalized therapy and start shipping almost immediately.
https://endpts.com/fda-hands-kite-pharma-a-pass-on-axi-cel-panel-review-car-t-ready-to-launch/
«Después de nada, o después de todo/ supe que todo no era más que nada.»