Autolus secures FDA approval for CAR-T cell therapy use in ALL
Aucatzyl is the first CAR-T cell therapy approved by the FDA with no requirement for a risk evaluation mitigation strategy ...
Cure Today6d
FDA Approves CAR-T Cell Therapy for Relapsed or Refractory B-Cell ALL
The CAR-T cell therapy Aucatzyl was approved for relapsed or refractory B-cell precursor acute lymphoblastic leukemia based ...
FDA approves new CAR-T competitor to Gilead’s Tecartus
Developer Autolus set a list price of $525,000 for its new cell therapy, which it will sell for a type of leukemia under the ...
Medscape6d
FDA Approved Obe-cel, a Novel CD19 CAR T Product for ALL
Obe-cel was designed to increase T-cell persistence and reduce T-cell exhaustion and was shown to improve response rates and survival, particularly in patients with low leukemia burden.
pharmaphorum4d
Autolus bags FDA approval for leukaemia cell therapy
Autolus has picked up its first product approval, getting an FDA green light for Aucatzyl as a treatment for patients with ...
FiercePharma4d
Autolus readies its CAR-T Aucatzyl to go after heavy hitter competition following FDA nod
Autolus is ready to hit the ground running after winning FDA approval for its Aucatzyl, a late entry to the heated CD19 CAR-T cell therapy arena. The therapy was cleared to treat relapsed or ...
The American Journal of Managed Care6d
FDA Approves Obe-Cel for R/R B-Cell Acute Lymphoblastic Leukemia
Obe-cel is the first FDA-approved CAR T-cell therapy for B-ALL without a REMS requirement, based on the FELIX trial's ...
GEN1d
CAR T-Cell Therapy Shows Efficacy in Young Patients with Incurable Brain Cancer
Immune-cell therapy shrank children's brain tumors, restored neurologic function and—for one participant—erased all ...
MedPage Today on MSN7d
Overcoming the Challenges of Applying CAR T-Cell Therapy to Solid Tumors
FDA approval of tarlatamab (Imdelltra) for small-cell lung cancer offers another example of progress. The novel bispecific ...