FDA Approvals, News & Updates

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.

The US Food and Drug Administration (FDA) approved pertuzumab (Perjeta; Genentech) for intravenous use in patients with HER2-positive metastatic breast cancer.

The FDA accelerated the approval of the oral mTOR kinase inhibitor everolimus (Afinitor; Novartis) for the treatment of kidney tumors (ie, renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).