Food and Drug Administration for three indications: T-cell non- Hodgkin's lymphoma, including CTCL; CLL and related leukemias including T-cell prolymphocytic leukemia, adult T-cell leukemia, and hairy cell leukemia; and for treatment of B-cell acute lymphoblastic leukemia
In addition, the European Medicines Agency has granted accelerated assessment to the Marketing Authorization Application for Kymriah for the treatment of children and young adults with r/r B-cell acute lymphoblastic leukemia
, or ALL, and for adult patients with r/r DLBCL who are ineligible for ASCT.
Launched in the UK in August 2016, CALM is an open label, dose-escalation study designed to evaluate safety, tolerability and antileukemic activity of UCART19 in patients with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia
The pediatric Phase I is an open label, non-comparative, monocenter study to evaluate the safety and ability of UCART19 to induce molecular remission in pediatric patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia
ahead of planned allogeneic haematopoeitic stem cell transplantation (allo-HSCT).
BioCryst also plans to initiate a Phase I/II trial in B-cell acute lymphoblastic leukemia
during the first half of 2005.
Food and Drug Administration today approved Blincyto (blinatumomab) to treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia
(B-cell ALL), an uncommon form of ALL.