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.

Erdafitinib (Balversa – Janssen), an oral kinase inhibitor, has received full approval from the FDA for treatment of locally advanced or metastatic urothelial carcinoma in adults with susceptible FGFR3 (fibroblast growth factor receptor) genetic alterations who had disease progression on or after at least one prior line of systemic therapy. It is not recommended for use in patients who are eligible for but have not received prior PD-1 (programmed death receptor-1) or PD-L1 (programmed death-ligand 1) inhibitor therapy. Erdafitinib is the first oral FGFR kinase inhibitor to be...

The FDA has approved tislelizumab (Tevimbra – BeiGene), a programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic esophageal squamous cell cancer in adults who received prior systemic chemotherapy that did not include a programmed death ligand-1 (PD-L1) inhibitor.

The FDA has approved the dual endothelin receptor antagonist aprocitentan (Tryvio – Idorsia) for use in combination with other antihypertensive drugs to treat hypertension in adults whose blood pressure is not adequately controlled on other drugs. Three other dual endothelin receptor antagonists, ambrisentan (Volibris, and generics), bosentan (Tracleer, and generics), and macitentan (Opsumit), are available in the US for treatment of pulmonary arterial hypertension.

The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

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....

Brella Sweat Control Patch (Candesant Biomedical), a sodium-containing transdermal patch, has been cleared by the FDA for in-office treatment of primary axillary hyperhidrosis in adults. It is the first patch to be approved in the US for this indication.

The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...

The RAS GTPase family inhibitor adagrasib (Krazati – BMS), which received accelerated approval for treatment of KRAS G12C (glycine-to-cysteine mutation at codon 12)-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in 2022, has now received accelerated approval from the FDA for use with cetuximab for treatment of KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC) in adults who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Adagrasib is the first KRAS inhibitor to be approved in the US for treatment...

Marstacimab-hncq (Hympavzi – Pfizer), a tissue factor pathway inhibitor (TFPI) antagonist, has been approved by the FDA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients ≥12 years old who have hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. It is the first hemophilia treatment to be approved in the US that targets an inhibitor of coagulation and the first to become available in prefilled pens and syringes for subcutaneous administration.