Elranatamab-bcmm (Elrexfio – Pfizer), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on the response rate and durability of response. Elranatamab is the second bispecific BCMA-directed CD3 T-cell engager to be approved for this indication; teclistamab (Tecvayli) was the...

Tisotumab vedotin-tftv (Tivdak – Seagen/Genmab), a tissue factor-directed antibody and microtubule inhibitor conjugate, has received full approval from the FDA for treatment of recurrent or metastatic cervical cancer that progressed on or after chemotherapy. It is the first antibody-drug conjugate to be approved for treatment of cervical cancer. The drug received accelerated approval from the FDA in 2021 for the same indication.

The FDA has approved delafloxacin (Baxdela – Melinta), an anionic fluoroquinolone antibiotic, for oral and parenteral treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is the first fluoroquinolone to be approved for treatment of MRSA.

The FDA has approved Alyftrek (Vertex), an oral fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators vanzacaftor, tezacaftor, and deutivacaftor, for once-daily treatment of cystic fibrosis (CF) in patients ≥6 years old who have at least one F508del mutation or another responsive mutation in the CFTR gene. This is the first approval for vanzacaftor and for deutivacaftor, a deuterated form of ivacaftor. Trikafta, a twice-daily oral fixed-dose combination of elexacaftor, tezacaftor, and ivacaftor, is FDA-approved for the same indication...

View the Comparison Table: Some Drugs for Plaque Psoriasis

Monoclate (Armour), a formulation of Factor VIII (antihemophilic factor; AHF) prepared by immunoaffinity chromatography, was recently approved for marketing by the US Food and Drug Administration. The new product is claimed to be more highly purified than older AHF formulations. Factor VIII concentrates commercially available in the USA are listed in the table below.

The copper T 380A (ParaGard - GynoPharma), a new intrauterine contraceptive device (IUD) soon to be marketed in the USA, will be one of only two IUDs available in this country. Progestasert (Alza), which gradually releases progesterone (Medical Letter, 18:65, 1976), is the other.

Naftifine hydrochloride 1% cream (Naftin - Herbert Laboratories), was recently approved by the US Food and Drug Administration (FDA) for topical treatment of tinea cruris and tinea corporis. It is available only by prescription.

Pneumocystis carinii pneumonia (PCP) occurs in nearly 80% of patients with the acquired immune deficiency syndrome (AIDS) and is a common cause of morbidity and mortality. Oral trimethoprim-sulfamethoxazole (Bactrim; and others), intravenous isethionate (Pentam 300) and other systemic drugs have been used to prevent PCP, but in AIDS patients, all of these agents can occasionally cause severe adverse effects (Medical Letter, 30:94, 1988). Recently, the US Food and Drug Administration approved marketing of aerosolized pentamidine isethionate (NebuPent - LyphoMed) for this indication. Another...

Nafarelin acetate (Synarel - Syntex), a synthetic analog of gonadotropin-releasing hormone (GnRH), was recently approved by the US Food and Drug Administration for treatment of endometriosis. The drug is available only in a nasal spray formulation.