The FDA has approved the interleukin-6 (IL-6) antagonist siltuximab (Sylvant – Janssen), a recombinant chimeric (human-mouse) monoclonal antibody, for treatment of multicentric Castleman's disease (MCD) in patients who are HIV negative and human herpesvirus-8 (HHV-8) negative. It is the first drug to be approved for this indication.

The FDA has approved idarucizumab (Praxbind – Boehringer Ingelheim) for urgent reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Idarucizumab is the first specific reversal agent to become available for one of the new oral anticoagulants.

The FDA has approved the combined use of the programmed death receptor-1 (PD-1) blocking antibody nivolumab (Opdivo) and the anti-CLA-4 antibody ipilimumab (Yervoy) for treatment of BRAF V600 wild-type unresectable or metastatic melanoma. This is the first immunotherapy combination to be approved for treatment of any type of cancer.

The FDA has approved the oral poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – Astra-Zeneca) as monotherapy for treatment of women with advanced ovarian cancer who have BRCA1/2 germline mutations and have received at least 3 prior lines of chemotherapy. Olaparib is the first PARP inhibitor to be approved in the US. It is approved outside the US for maintenance treatment of relapsed BRCA-mutated ovarian cancer.

Dichlorphenamide (Keveyis – Taro), an oral carbonic anhydrase inhibitor, has been approved by the FDA for treatment of primary hypokalemic and hyperkalemic periodic paralysis and related variants. Dichlorphenamide is the first drug to be approved in the US for this indication. It was approved as Daranide in 1958 for treatment of glaucoma, but had not been marketed since 2002.

The FDA has approved the atypical antipsychotic pimavanserin (Nuplazid – Acadia) for treatment of hallucinations and delusions associated with Parkinson's disease. It is the first drug to be approved in the US for this indication.

A reader asked whether healthcare providers should avoid prescribing the angiotensin receptor blocker (ARB) olmesartan medoxomil (Benicar, and others) because it can cause severe GI adverse effects.In 2013, the FDA warned that olmesartan can cause sprue-like enteropathy, a condition characterized by intestinal villous atrophy, severe chronic diarrhea, and significant unintended weight loss. The warning was based on 23 cases of serious sprue-like enteropathy associated with use of olmesartan, some occurring years after starting the drug. All patients improved after stopping olmesartan; 10 had a...

The FDA has approved the oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) for extended adjuvant treatment of adults with early-stage, human epidermal growth factor receptor 2 (HER2)-positive breast cancer, following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur.

Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.

Consensi (Coeptis/Burke), a fixed-dose combination of the calcium channel blocker amlodipine (Norvasc, and others) and the COX-2 selective NSAID celecoxib (Celebrex, and generics), has been approved by the FDA for treatment of patients who have hypertension and osteoarthritis.