The FDA has approved Anjeso (Baudax Bio), an IV formulation of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam, for once-daily treatment of moderate to severe pain in adults. Oral meloxicam (Mobic, and others), which is only indicated for treatment of chronic pain associated with osteoarthritis or rheumatoid arthritis, has been available for 20 years. IV formulations of ketorolac, ibuprofen (Caldolor), and acetaminophen (Ofirmev) are also available for treatment of pain.

Intensive chemotherapy, with or without total body radiation, followed by bone marrow transplantation is now widely used in the treatment of malignant diseases. The drugs and radiation needed to try to eradicate the malignancy unavoidably destroy the bone marrow; intravenous infusion of bone marrow cells restores the marrow by repopulating it. Diseases for which bone marrow transplantation has been used include the leukemias and lymphomas, breast cancer, neuroblastoma, ovarian cancer, germ cell tumors, melanoma, multiple myeloma, and malignant gliomas (NC Gorin, Am J Clin On-col, 14...

CroFab, an antigen-binding-fragment (Fab) antivenom of ovine origin, has been approved by the FDA for treatment of North American rattlesnake envenomation.

Belimumab (Benlysta – Human Genome Sciences/GlaxoSmithKline) has been approved by the FDA for treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE). It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in >50 years.

The FDA has approved deferiprone (de fer’ i prone; Ferriprox – ApoPharma), an oral chelating agent available in Europe since 1999, for use as a second-line treatment of iron overload due to blood transfusions (transfusional hemosiderosis) in patients with thalassemia. Two other iron chelating agents, deferoxamine (Desferal, and others), which is usually administered subcutaneously, and oral deferasirox (Exjade), are available for use as first-line therapy in the US.

The FDA has approved a new formulation (Exparel – Pacira) of the local anesthetic bupivacaine (Marcaine, and others) for use in the management of postsurgical pain in adults.

Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET bispecific antibody, has received accelerated approval from the FDA for IV treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. It is the first bispecific antibody to become available in the US for this indication. Accelerated approval of the drug was based on the overall response rate and duration of response.

The adeno-associated virus (AAV) vector-based gene therapy delandistrogene moxeparvovec-rokl (Elevidys – Sarepta) received accelerated approval from the FDA in 2023 for treatment of ambulatory children 4-5 years old with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. It has now received full approval for use in ambulatory patients ≥4 years old and accelerated approval for use in nonambulatory patients with DMD.

The amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi – Eisai/Biogen) has now been approved by the FDA for once-monthly use for treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. It was previously approved only for administration once every 2 weeks. Now, lecanemab can be given every 4 weeks after an 18-month initiation phase of biweekly administration.

Antimicrobial prophylaxis can decrease the incidence of postoperative surgical site infection after some procedures. Since the last Medical Letter article on this subject, consensus guidelines have been published. Recommendations for prophylaxis in specific surgical procedures are listed in Table 1.