scout

All Oncology News

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

The European Medicines Agency has validated a Marketing Authorization Application for belantamab mafodotin for the treatment of patients with relapsed/refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor, and a CD38-directed monoclonal antibody.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease.

The European Medicines Agency has validated a Marketing Authorization Application for tucatinib in combination with trastuzumab and capecitabine for the treatment of adult patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases, who have received ≥2 prior anti-HER2 treatment regimens.

Darolutamide plus androgen deprivation therapy (ADT) led to a significant improvement in overall survival (OS) compared with placebo and ADT in patients with nonmetastatic castration-resistant prostate cancer, according to results from a preplanned final OS analysis of the phase III ARAMIS trial.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for February 26, 2020, to discuss data supporting a supplemental biologics license application for intravenous ramucirumab injection for use in combination with erlotinib in the frontline treatment of patients with metastatic non–small cell lung cancer whose tumors harbor EGFR Ex19del or Ex21 substitution mutations.

A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare for manufacturing and marketing approval of cabozantinib for the treatment of patients with unresectable hepatocellular carcinoma following progression on prior systemic therapy.