858-449-1310 contact@somatek.com

This year FDA moved to approve 19 new biological licenses including biologics for the treatment of blood cancers and hemophilia.

Notably, 2017 saw the approval of a new type of immunotherapy using genetically engineered, patient-derived T-cells, so-called CAR-T cells. Clinical trials have shown that CAR-T cells can induce long-lasting remissions, even cures, in certain types of malignancies and approval of CAR-T cells was greeted with considerable excitement in the medical community and among patient advocates. One type of CAR-T cells, Novartis’s KYMRIAH, was approved for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. Another type of CAR-T cells, Kite Pharmaceutical”s YESCARTA, was approved for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Visit FDA’s website for more information regarding approved applications and approval dates here >>