Palbociclib (Ibrance – Pfizer), an oral cyclin-dependent kinase inhibitor, has been approved by the FDA for use in combination with the aromatase inhibitor letrozole (Femara, and generics) for first-line treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. It is the first cyclin-dependent kinase inhibitor to become available in the US.

The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

The FDA has announced that it is requiring changes in the labeling of systemic fluoroquinolones to warn that the risk of serious adverse effects, including tendinitis, peripheral neuropathy and CNS effects, generally outweighs their benefit for the treatment of acute sinusitis, acute exacerbations of chronic bronchitis, and uncomplicated urinary tract infections. For these infections, the new labels will recommend reserving fluoroquinolones for patients with no other treatment options.

Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.

The FDA has approved Tarpeyo (Calliditas), a delayed-release capsule formulation of the corticosteroid budesonide, to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN; also called Berger's disease) who are at risk of rapid disease progression. It is the fi rst drug to be approved in the US for this indication. Oral formulations of budesonide have been available for years for treatment of inflammatory bowel disease.

Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma after ≥2 lines of systemic therapy. Accelerated approval was based on response rates and durability of response. Glofitamab is the second T-cell-engaging bispecific antibody to be approved in the US for treatment of DLBCL; epcoritamab-bysp (Epkinly), which is given...

Tovorafenib (Ojemda – Day One), a type II RAF kinase inhibitor, has received accelerated approval from the FDA for treatment of patients ≥6 months old with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement or a BRAF V600 mutation. Tovorafenib is the first systemic treatment to be approved in the US for pediatric low-grade gliomas with BRAF fusions. Accelerated approval of tovorafenib was based on response rates and duration of response.

Berdazimer 10.3% gel (Zelsuvmi – Ligand), a first-in-class nitric oxide-releasing agent, has been approved by the FDA for topical treatment of molluscum contagiosum in patients ≥1 year old. It is the second drug to become available in the US for treatment of molluscum contagiosum and the first that can be applied by the patient or caregiver at home; cantharidin 0.7% solution (Ycanth), which is applied by a healthcare professional, was approved earlier for use in patients ≥2 years old.

Nebivolol (Bystolic - Forest) is a new beta-blocker that has been approved by the FDA for treatment of hypertension. It has been marketed in Europe since 1999 for treatment of hypertension and heart failure.

Nabilone (Cesamet - Lilly), a synthetic cannabinoid chemically related to tetrahydrocannabinol (THC), the main active ingredient in marijuana, was recently marketed in the USA for oral treatment of nausea and vomiting associated with cancer chemotherapy. Oral THC itself, known generically as dronabinol (Marinol), is also commercially available as an antiemetic for cancer patients (Medical Letter, 27:97, 1985). Other drugs used for this purpose include metoclopramide (Reglan - Medical Letter, 24:67, 1982), prochlorperazine (Compazine; and others), haloperidol (Haldol; and others), and...