The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

The recent increase in deaths due to overdose of heroin and prescription opioids in the US has renewed interest in the opioid antagonist naloxone, particularly in making it available to first responders and to relatives and close friends of persons using heroin or taking prescription opioids. IV or IM administration by healthcare professionals is preferred, but peripheral venous access may be difficult to obtain in IV drug abusers, and exposure to their blood may be hazardous.

The FDA has approved the Minimed 670G (Medtronic), a hybrid closed-loop insulin delivery system for use in patients ≥14 years old with type 1 diabetes. The system uses an algorithm to automatically adjust basal insulin doses based on readings from a continuous glucose monitor (CGM). It fully automates basal insulin delivery in "auto" mode, but is considered a "hybrid" system (not a true "artificial pancreas") because it requires some action by the patient. The 670G system is expected to become available in Spring 2017.

The FDA has approved ferric pyrophosphate citrate solution (Triferic – Rockwell Medical) to maintain hemoglobin concentrations in adults with hemodialysis-dependent chronic kidney disease. Triferic is the first iron replacement product that is added into the hemodialysis solution at each dialysis procedure.

Icosapent ethyl (Vascepa – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA for use as an adjunct to maximally tolerated statin therapy to reduce the risk of major adverse cardiovascular events in adults with hypertriglyceridemia (≥150 mg/dL) who have either established cardiovascular disease (CVD) or diabetes and ≥2 additional risk factors for CVD. It is the only omega-3 polyunsaturated fatty acid (PUFA) product to be approved in the US for this indication. Icosapent ethyl and two other omega-3 PUFA prescription products (Lovaza, Epanova),...

Plenity (Gelesis), a nonsystemic oral superabsorbent hydrogel formulation of cellulose and citric acid is now available. It was cleared by the FDA in 2019 to aid in weight management together with diet and exercise in overweight and obese adults (BMI of 25-40 kg/m2). It is classified by the FDA as a device because the contents of the capsule are not absorbed systemically. Plenity is the first ingested, transient, space-occupying hydrogel to be marketed in the US and the only weight management treatment available by prescription for patients with a BMI of 25-30 kg/m2, regardless of...

Fensolvi (Tolmar), a long-acting subcutaneous formulation of the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate, has been approved by the FDA for treatment of central precocious puberty (CPP) in children ≥2 years old. It is the first formulation of the drug to be approved for SC administration once every 6 months. IM formulations of leuprolide acetate, which are given once monthly or every 3 months, and the GnRH agonists histrelin acetate (Supprelin LA) and triptorelin (Triptodur) have been available for years for treatment of CPP.

The FDA recently approved axicabtagene ciloleucel (Yescarta – Kite), a CD19-directed genetically modified cellular product, for treatment of large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line treatment. It was previously approved for treatment of relapsed or refractory B-cell lymphoma after ≥2 lines of systemic therapy and for treatment of relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells,...

Teclistamab-cqyv (Tecvayli – Janssen), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.

The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.