FDA Approvals, News & Updates

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).

The US Food and Drug Administration (FDA) approved the oral agent pazopanib (Votrient; GlaxoSmith-Kline) for the treatment of patients with advanced soft-tissue sarcoma who have previously received chemotherapy.

The US Food and Drug Administration (FDA) approved an updated label for imatinib (Gleevec; Novartis) for the use of the drug in adults after the surgical removal of CD117-positive gastrointestinal stromal tumors (GIST).

A new House bill—the Drug Shortage Prevention Act (H.R. 3839)— received bipartisan support to expedite the FDA review of drugs in shortage, improve communication within the agency and with stakeholders about possible shortages, and increase Drug Enforcement Administration (DEA) quotas for medications in short supply.

The US Food and Drug Admini­s­tration (FDA) approved a new indication for imatinib (Gleevec; Novartis) for the treatment of children with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL), the most common type of pediatric cancer.

The FDA has issued a boxed warning for brentuximab vedotin (Adcetris, Seattle Genetics) related to the risk of John Cunningham virus infec­tion, leading to progressive multifocal leu­ko­­encephalopathy (PML) and death in patients who take brentuximab to treat Hodgkin lymphoma or systemic anaplastic large-cell lymphoma.

The FDA has accepted a New Drug Application (NDA) for bosutinib (Pfizer), an oral dual Src and Abl tyrosine kinase inhibitor, as a second-line therapy for adult patients with previously treated Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML).