FDA Approvals, News & Updates

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).

The apoptotic topical gel ingenol mebutate (Picato; Leo Pharma) has received FDA approval for the treatment of actinic keratosis, a precancerous condition that can progress to squamous-cell carcinoma.

The FDA approved a new, subcutaneous route of administration for the proteasome inhibitor bortezomib (Velcade; Millennium) as an alternative method to the previously approved intravenous (IV) form of the drug in all the FDA indications.