The guanylate cyclase-C receptor agonist linaclotide (Linzess – Abbvie/Ironwood) was first approved by the FDA in 2012 for treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. The drug has now been approved for treatment of functional constipation in patients 6-17 years old. Linaclotide is the only drug to be approved in the US for treatment of functional constipation.

Talquetamab-tgvs (Talvey – Janssen), a bispecific GPRC5D-directed 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 the response rate and durability of response. Talquetamab is the first bispecific GPRC5D-directed T-cell engager to be approved in the US

The oral kinase inhibitor osimertinib (Tagrisso – AstraZeneca), which has been available for years for treatment of non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, has now been approved for treatment of unresectable stage III EGFR-mutated NSCLC. About 20-30% of patients with NSCLC have locally advanced stage III NSCLC, and 60-90% of these patients have unresectable disease. Osimertinib is the first targeted therapy to be approved for the new indication.

Saxagliptin (Onglyza - Bristol-Myers Squibb), the second oral dipeptidyl peptidase-4 (DPP-4) inhibitor to be marketed in the US, has been approved by the FDA for treatment of adults with type 2 diabetes.

The FDA has approved Akynzeo (Helsinn/Eisai), an oral fixed-dose combination of the substance P/neurokinin 1 (NK1) receptor antagonist netupitant and the serotonin-3 (5-HT3) receptor antagonist palonosetron, for prevention of acute and delayed nausea and vomiting associated with cancer chemotherapy in adults. Akynzeo is the first product to combine drugs from these two classes. Palonosetron (Aloxi) is also available as a single agent for prevention of chemotherapy-induced and postoperative nausea and vomiting. Netupitant is the second substance P/NK1 receptor antagonist to be...

The FDA has approved lemborexant (Dayvigo – Eisai), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. It is the second orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) was the first.

Sitagliptin phosphate (Januvia - Merck) is the first dipeptidyl-peptidase-4 (DPP-4) inhibitor to be marketed for treatment of type 2 diabetes. It has been approved by the FDA for oral use as monotherapy or in combination with metformin (Glucophage, and others), pioglitazone (Actos) or rosiglitazone (Avandia).

The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, previously approved by the FDA as Ozempic to treat type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, has now been approved in a higher dose as Wegovy (Novo Nordisk) for chronic weight management in adults with or without type 2 diabetes who have a body mass index (BMI) ≥30 kg/m2 or a BMI ≥27 kg/m2 and ≥1 weight-related comorbidity (e.g., hypertension, dyslipidemia). An oral formulation of semaglutide...

Gonadorelin (goe nad oh rell'; in) acetate (Lutrepulse - Ortho), a synthetic decapeptide identical in amino acid sequence to human gonadotropin-releasing hormone (GnRH), was recently approved by the US Food and Drug Administration for treatment of primary hypothalamic amenorrhea. Gonadorelin hydrochloride (Factrel) was previously available for diagnostic use (Medical Letter, 25:106, 1983). Analogs of GnRH have been used to treat endometriosis and advanced cancer of the prostate (Medical Letter, 27:71, 1985).

The February 14th issue of The Medical Letter reviewed natalizumab (Tysabri - Biogen Idec), a new monoclonal antibody that was granted accelerated approval because it decreased the number of relapses in patients with multiple sclerosis. On February 28th, the FDA issued a Public Health Advisory announcing that marketing of the drug had been suspended because 2 patients who had been treated with natalizumab for more than 2 years had developed progressive multifocal leukoencephalopathy, a rare, often fatal disease...