Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation. It is the second drug that targets cancer metabolism to be approved for this indication; ivosidenib (Tibsovo) was approved in 2022.

The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases. The drug received accelerated approval for the same indication in 2020 based on initial overall response rates and duration of response.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangements. It is the first targeted therapy to be approved in the US for this indication. The drug received accelerated approval from the FDA in 2020 for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements.

About 60% of men ≥60 years old have clinically relevant prostatic enlargement due to benign prostatic hyperplasia (BPH). The goals of treatment are to decrease lower urinary tract symptoms and to prevent disease progression and complications such as acute urinary retention. The American Urologic Association's guidelines for treatment of BPH were recently updated.

The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq – Abbvie) have been approved by the FDA for treatment of moderate to severe atopic dermatitis.

As cocaine continues to be widely available in the USA (Medical Letter, 28:69, 1986), new problems associated with its use continue to emerge. Some recent reports indicate that use of the drug during pregnancy can damage the fetus, lead to abortion or premature labor, and cause toxic effects in the newborn infant.

Misoprostol (Cytotec - Searle), a synthetic methyl analog of prostaglandin E1, was recently approved by the US Food and Drug Administration for prevention of gastric ulcers in high-risk patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In other countries, the drug is also marketed for treatment of idiopathic peptic ulcers unrelated to NSAIDs.

Flurbiprofen (Ansaid - Upjohn), a nonsteroidal anti-inflammatory drug (NSAID) available in some countries since 1977, was recently approved by the US Food and Drug Administration for treatment of rheumatoid arthritis and osteoarthritis. Flurbiprofen is a fluorinated phenylalkanoic acid derivative structurally related to ibuprofen (Motrin;and others).

Quazepam (Doral - Baker Cummins, Wallace) is a trifluoroethyl benzodiazepine made by Schering and approved in 1985 by the US Food and Drug Administration for treatment of insomnia. Like other benzodiazepines, it is a Schedule IV controlled substance.Quazepam (Doral - Baker Cummins, Wallace) is a trifluoroethyl benzodiazepine made by Schering and approved in 1985 by the US Food and Drug Administration for treatment of insomnia. Like other benzodiazepines, it is a Schedule IV controlled substance.

FK 506 (Fujisawa), an immunosuppressant similar in activity to cyclosporine (Sandimmune - Medical Letter 25:77, 1983), is currently under investigation in the USA, Europe, and Japan for prevention of organ transplant rejection.