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.
Leukemias/lymphomas/ And Other Hematologic Cancers
Potential Med Errors Prompt FDA Action on Vinca Alkaloid Labeling
Chemotherapy agents such as vincristine sulfate injection, vinblastine sulfate injection, and vinorelbine tartrate injection should only be prepared in IV infusion bags.
Xalkori Approved for Anaplastic Large Cell Lymphoma in Children, Young Adults
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.
Sitagliptin Promising Addition for Preventing Acute GVHD
Low incidence of grade II to IV acute GVHD seen in patients undergoing myeloablative allogeneic hematopoietic stem cell transplantation
New Drugs Approved in 2020
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Iclusig Approved for Resistant or Intolerant Chronic-Phase CML
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.
Xpovio Multiple Myeloma Indication Expanded
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.
Biosimilar Riabni Gets FDA Approval
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
Loncastuximab Tesirine Gets Priority Review for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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.
FDA Grants Full Approval to Venclexta for Acute Myeloid Leukemia
The full approval was based on efficacy and safety data from the phase 3 VIALE-A (M15-656) and VIALE-C (M16-043) studies.
