The injectable interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) is now FDA-approved for treatment of moderately to severely active Crohn's disease (CD) in adults. Mirikizumab was approved in 2023 for treatment of ulcerative colitis. Two other IL-23 antagonists, risankizumab (Skyrizi) and guselkumab (Tremfya), are also approved for treatment of CD.

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.

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.

A reader asked us to review use of the phosphodiesterase-5 (PDE5) inhibitor sildenafil for treatment of Alzheimer's disease (AD).

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has now been approved by the FDA for use in combination with abiraterone (Zytiga, and others) and either prednisone or prednisolone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib was previously approved by the FDA for treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombinant repair (HRR) genemutated mCRPC who progressed on prior treatment with...

The FDA has approved osimertinib (Tagrisso – AstraZeneca), an oral kinase inhibitor, for adjuvant treatment of non-small cell lung cancer (NSCLC) after tumor resection in adults who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Osimertinib is the first targeted therapy to be approved in the US for this indication. The drug was previously approved for first-line treatment of adults with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations and for treatment of EGFR T790M mutation-positive NSCLC in adults whose disease progressed...

Akeega (Janssen), a fixed-dose combination of the oral poly(ADP-ribose) polymerase (PARP) inhibitor niraparib (Zejula) and the antiandrogen abiraterone acetate (Zytiga, and others), has been approved by the FDA for use in combination with prednisone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Niraparib has been available since 2017 for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer. Abiraterone acetate has been available since 2011 for treatment of CRPC...

Low-intensity extracorporeal shockwave therapy similar to that used to fragment kidney stones or gallstones is a new option for treatment of erectile dysfunction that is now being advertised extensively in the US. It has not been approved by the FDA for treatment of erectile dysfunction.

The FDA has authorized over-the-counter (OTC) sale of a nonmedicated alcohol-based gel (Eroxon – Futura) for treatment of erectile dysfunction (ED) in males ≥22 years old. Eroxon is the only FDA-approved OTC and topical treatment for erectile dysfunction. It is also available in the UK and the EU.

The FDA has licensed PreHevbrio (VBI Vaccines), a recombinant, 3-antigen, 3-dose hepatitis B vaccine, for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults. It has been available in Israel since 2000.