Tecvayli Approved for Relapsed or Refractory Multiple Myeloma
The approval was based on data from the MajesTEC-1 study which included 110 adults with relapsed or refractory multiple myeloma who had previously received ≥3 prior therapies.
The approval was based on data from the MajesTEC-1 study which included 110 adults with relapsed or refractory multiple myeloma who had previously received ≥3 prior therapies.
The British Society of Hematology has updated their guidelines on the use of irradiated blood components.
In the CRL, the FDA recommended that the Company conduct at least 1 additional randomized, clinical study.
For patients with myelodysplastic syndrome, 5-azacitidine treatment delays showed some links to outcomes, while dose reductions had less impact.
Recent studies have better elucidated the link between clonal hematopoiesis and hematologic malignancies.
The FDA has granted accelerated approval to Tecartus™ (brexucabtagene autoleucel; Kite Pharma) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.
Premyelodysplastic syndrome blood kinetics are linked to both disease risk and overall survival.
Tazverik, a methyltransferase inhibitor, is already indicated for the treatment of patients aged ≥16 years with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
The FDA has approved Reblozyl® (luspatercept–aamt; Bristol-Myers Squibb and Acceleron) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes.
The FDA has approved Ziextenzo (pegfilgrastim-bmez; Sandoz), a biosimilar to Neulasta.