Narsoplimab Under Review for Stem Cell Transplant-Associated Thrombotic Microangiopathy
The FDA has accepted for filing and granted Priority Review to narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
The FDA has accepted for filing and granted Priority Review to narsoplimab for hematopoietic stem cell transplant-associated thrombotic microangiopathy.
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
The approval was based on data from an open-label phase 1/2 trial in patients aged 1 to 21 years that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least 1 systemic treatment.
Low incidence of grade II to IV acute GVHD seen in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation
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The sNDA approval is based on efficacy and safety data from the open-label phase 2 OPTIC trial and 5-year data from the phase 2 PACE trial.
The approval was based on data from the BOSTON trial that assessed Xpovio in combination with bortezomib and dexamethasone in 402 adults with relapsed or refractory multiple myeloma who had received 1 to 3 prior therapies.
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
Loncastuximab tesirine is an antibody drug conjugate composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine dimer cytotoxin.
The full approval was based on efficacy and safety data from the phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies.