FDA Approvals, News & Updates

“Non–small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Mark A. Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of phase 2 and phase 3 clinical trials of paclitaxel protein-bound in lung cancer.

The FDA accelerated the approval of vincristine sulfate liposome injection (Marqibo; Talon Therapeutics) for the treatment of patients with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL), a rare type of leukemia, with a second or greater relapse after treatment with ≥2 antileukemia therapies. The drug is designated as an orphan product.

The FDA approved tbo-filgrastim (Neutro­val; Sicor Biotech UAB, a member of Teva Corporation) to reduce the duration of severe neutropenia in pa­tients with cancer receiving chemotherapy.

Using its priority review process, the US Food and Drug Administration (FDA) approved the oral multikinase inhibitor regorafenib (Stivarga; Bayer HealthCare Pharmaceuticals) for the treatment of patients with metastatic colorectal cancer (mCRC).

The FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended in an 11 to 0 vote (and 1 absentee) to approve carfilzomib (Kyprolis; Onyx), a new-generation proteasome inhibitor, for the treatment of patients with refractory and relapsed multiple myeloma who have failed at least 2 other myeloma therapies—the proteasome inhibitor bortezomib (Velcade) and the immunomodulatory drug lenalidomide (Revlimid).