Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF therapy, and, in patients with RAS wild-type mutations, anti-EGFR therapy. The drug can be used in patients with mCRC regardless of biomarker status. Fruquintinib is the first drug to become available in the US for treatment of mCRC that targets 3 VEGF receptor kinases.

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.

The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced adults whose current regimen is failing. Lenacapavir is the third drug to be approved exclusively for treatment of MDR-HIV; the intravenously administered CD4-directed antibody ibalizumab-uiyk (Trogarzo) and the orally administered HIV-1 gp120-directed attachment inhibitor fostemsavir (Rukobia) were approved earlier.

The FDA has approved vonoprazan (Voquezna – Phathom), a potassium-competitive acid blocker, for healing and maintenance of healing of all grades of erosive esophagitis and relief of associated heartburn in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults.

The FDA has approved use of oral leucovorin calcium (folinic acid) for treatment of cerebral folate transport deficiency in patients who have a confirmed variant in the folate receptor 1 gene (FOLR1-CFTD). It is the first drug to be approved for this extremely rare disorder.

The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole is the first drug to be approved in the US specifically for treatment of RVVC.

The FDA has approved remibrutinib (Rhapsido – Novartis), an oral Bruton's tyrosine kinase (BTK) inhibitor, for treatment of chronic spontaneous urticaria in adults who remain symptomatic despite H₁-antihistamine treatment. Remibrutinib is the first oral drug to be approved in the US for this indication.

The FDA has approved the oral substance P/neurokinin-1 (NK-1) receptor antagonist tradipitant (Nereus – Vanda) for prevention of vomiting induced by motion in adults. Tradipitant is the first drug to be approved for motion sickness in more than 40 years. Other oral substance P/NK-1 receptor antagonists (i.e., aprepitant, rolapitant, and netupitant) have been available for years for prevention of chemotherapy-induced nausea and vomiting.

The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader (SERD) fulvestrant (Faslodex, and generics) for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults with one or more PIK3CA/AKT1/PTEN-alterations who had disease progression on at least one endocrine-based regimen for metastatic disease or recurrence on or within 12 months of completing...