NDA Submitted for Crizotinib for NSCLC

Pfizer announced that its New Drug Application (NDA) for Crizotinib, an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted priority review status by the FDA.

Fusilev Approved for Use in Colorectal Cancer

Fusilev Approved for Use in Colorectal Cancer

Spectrum Pharmaceuticals announced that Fusilev (levoleucovorin for injection) has gained an indication in combination with 5-fluorouracil for the palliative treatment of patients with advanced metastatic colorectal cancer.

BLAs Accepted for Brentuximab Vedotin

Seattle Genetics announced that the FDA has accepted for filing two Biologics License Applications (BLAs) for brentuximab vedotin, including one for the treatment of patients with relapsed or refractory Hodgkin lymphoma and one for relapsed or refractory systemic anaplastic large cell lymphoma.