FDA Approvals, News & Updates

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).

The US Food and Drug Administration (FDA) has approved the Access Hybritech p2PSA (Beckman Coulter) test, which measures a form of prostate-specific antigen (PSA) called [-2]proPSA in the blood and can help men whose PSA test scores are elevated decide whether they should have a biopsy to rule out prostate cancer.

The FDA has added new safety information to the label and medication guide for lenalidomide (Revlimid; Celgene), noting that lenalidomide maintenance treatment in patients with newly diagnosed multiple myeloma is associated with an increased risk for developing new primary malignancies.