Company discontinues phase 3 trial of vadastuximab talirine in AML

AML cells
On the advice of the Independent Data Monitoring Committee, Seattle Genetics is discontinuing the phase 3 CASCADE clinical trial of vadastuximab talirine as frontline treatment in older patients with acute myeloid leukemia (AML). The company is also suspending patient enrollment and treatment in all its vadastuximab trials, including the ongoing phase 1/2 trial in frontline high-risk myelodysplastic syndromes (MDS). [Read Article]

Biosimilar rituximab approved in Europe

Monoclonal antibodies
Photo by Linda Bartlett
The European Commission (EC) has approved the Sandoz biosimilar rituximab (Rixathon®) for use in the European Economic Area (EEA). Rixathon is approved for all indications of the reference medicine, MabThera®, including non-Hodgkin lymphoma—follicular lymphoma and diffuse large B-cell lymphoma—chronic lymphocytic leukemia, and immunologic diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. This approval allows Rixathon to be marketed in the member states of the European Union and Iceland, Liechtenstein, and Norway . . . [Read Article]

FDA approves daratumumab-POM-Dex combo for MM

Daratumumab (Darzalex)
Photo courtesy of Janssen
The US Food and Drug Administration (FDA) has approved daratumumab (Darzalex®) in combination with pomalidomide (POM) and dexamethasone (dex) for the treatment of multiple myeloma (MM) in patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor (PI). The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with MM who had at least 1 prior therapy. Daratumumab is also approved by the FDA as monotherapy in MM patients who had . . . [Read Article]