The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options. The combination is not approved for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition and dabrafenib is not approved for use in patients with wild-type BRAF...

The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic treatment for a recurrent episode of CDI in adults. Rebyota is the first microbiome-based treatment to be approved for this indication. It is not approved for initial treatment of CDI. Fecal microbiota transplantation (FMT) has been used in patients with multiple CDI recurrences.

The FDA has required the manufacturer of the secondgeneration antipsychotic quetiapine (Seroquel) to add a warning to the labeling saying that use of the drug should be avoided in combination with other drugs that prolong the electrocardiographic QTc interval (Table 1). The warning is based only on postmarketing reports of QT-interval prolongation in patients who overdosed on the drug, had concomitant illness, or were taking other drugs known to cause electrolyte imbalances or increase the QT interval. QT prolongation can lead to torsades de pointes, a potentially fatal cardiac...

After our article on nivolumab (Opdivo – BMS) for treatment of metastatic melanoma and metastatic squamous non-small cell lung cancer (NSCLC) was published in the most recent issue of The Medical Letter (June 8, 2015),1 some new data became available supporting the efficacy of the drug in previously untreated melanoma and previously treated nonsquamous NSCLC.MELANOMA – In a double-blind trial, 945 patients with previously untreated, unresectable stage III or IV melanoma were randomized to receive ipilimumab, nivolumab, or combination therapy with ipilimumab and nivolumab. Progression-free...

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) in children as young as 6 months. The bivalent Pfizer vaccine is authorized for use as the final dose of a 3-dose primary series in children 6 months to 4 years old. The bivalent Moderna vaccine is authorized for use as a booster dose in children 6 months to 5 years old who completed a primary...

Insulin glargine-aglr (Rezvoglar – Lilly), which was approved by the FDA as a biosimilar to the reference product Lantus in 2021 and received interchangeability status with Lantus in 2022, will become available in the US on April 1, 2023. It is the second biosimilar insulin product to be designated as interchangeable with Lantus; Semglee was the first. Rezvoglar did not receive interchangeability status with Lantus at the time of its initial approval because the manufacturer of Semglee had exclusivity for 12 months.

Percutaneous coronary intervention (PCI), such as balloon angioplasty or stent placement, predisposes to subsequent thrombosis. The current pharmacologic approach to prevention of this problem combines an anticoagulant with one or more antiplatelet drugs.

Ferumoxytol (Fer yoo mox’ i tole; Feraheme – AMAG), an intravenous (IV) iron replacement product, has been approved by the FDA for treatment of iron deficiency anemia in adults with chronic kidney disease. Iron deficiency anemia is common in chronic kidney disease and may be associated with decreased absorption from the gastrointestinal tract, limiting the usefulness of oral iron replacement. IV iron replacement can lower the dose requirement for erythropoiesis-stimulating drugs, particularly in patients on dialysis

The FDA has approved naloxegol (Movantik – AstraZeneca), a pegylated derivative of the opioid antagonist naloxone, for oral treatment of opioid-induced constipation in adults with chronic noncancer pain. It is the only oral opioid antagonist approved for this indication in the US.

The FDA has approved isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.