The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine (Fludara, and others) and alemtuzumab (Campath). It is the second anti-CD20 antibody approved for treatment of CLL; rituximab (Rituxan), a chimeric murine/human antibody, was the first.

The FDA has approved cyclosporine 0.09% ophthalmic solution (Cequa – Sun) to increase tear production in patients with keratoconjunctivitis sicca (dry eye disease). Restasis, a 0.05% cyclosporine emulsion, was approved in the US in 2003 for the same indication.

Azelastine hydrochloride, a histamine-H1 receptor antagonist, has been marketed as a 0.1% nasal spray (Astelin - Wallace) for treatment of seasonal allergic rhinitis. Corticosteroid and cromolyn sodium nasal sprays are also available for this indication (Medical Letter, 37:5, 1995). Cromolyn sodium (Nasalcrom) has now been approved for over-the-counter use.

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

Obeticholic acid (Ocaliva – Intercept), a farnesoid X receptor agonist, has been approved by the FDA for treatment of primary biliary cholangitis; it is indicated for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso, and others) in adults with an inadequate response to UDCA and as monotherapy in adults unable to tolerate UDCA. Obeticholic acid is the second drug to be approved for this indication; UDCA was the first.

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

Ixabepilone (ix ab ep' i lone; Ixempra - Bristol-Myers Squibb), a semisynthetic epothilone analog, has been approved by the FDA for treatment of advanced breast cancer. It is indicated for use in combination with capecitabine (Xeloda - Roche) for treatment of locally advanced or metastatic breast cancer after failure of an anthracycline such as doxorubicin (Adriamycin) and a taxane such as paclitaxel (Taxol, and others). It is also approved as monotherapy for treatment of metastatic or locally advanced breast cancer after an anthracycline, a taxane and capecitabine have...

The FDA has approved inotuzumab ozogamicin (Besponsa – Pfizer), a humanized anti-CD22 monoclonal antibody conjugated to the cytotoxic antibiotic calicheamicin, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults. It is the first CD22-directed antibody-drug conjugate to be approved in the US.

The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for short-term treatment (≤2 weeks) of dry eye disease. It is the first ocular corticosteroid to be approved for this indication. Other formulations of loteprednol are approved for treatment of steroid-responsive ocular inflammatory conditions, inflammation after ocular surgery, and seasonal allergic conjunctivitis.

The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.