FDA Approvals, News & Updates

Drug shortages have hit the oncology community hard. Determined to alleviate the much-publicized drug shortage associated with doxorubicin hydrochloride liposome injection (Doxil; Janssen), the FDA expedited the approval of the first generic version of this agent, which is produced by Sun Pharma Global FZE (Sun).

Using its priority review process, the FDA approved a new indication for abiraterone acetate (Zytiga; Janssen Biotech) for the treatment of patients with metastatic, castration-resistant prostate cancer (CRPC) before chemotherapy.

The US Food and Drug Admin­istration (FDA) approved ponatinib (Iclusig; ARIAD Pharmaceuticals) under its accelerated program for the treatment of patients with chronic- phase (CP), accelerated-phase (AP), or blast-phase (BP) chronic myeloid leukemia (CML) that is resistant to or intolerant to tyrosine kinase inhibitor (TKI) therapy or to Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL) that is resistant to or intolerant to TKI therapy. The recommended dose is 45 mg, taken orally once daily, with no regard to food.

The US Food and Drug Administration (FDA) approved omacetaxine mepesuccinate (Synribo; Teva Pharmaceutical) to treat adults with chronic myelogenous leukemia (CML), a hematologic disease. An estimated 5430 Americans will be diagnosed with CML in 2012, according to the National Institutes of Health.

“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).