Epcoritamab-bysp (Epkinly – Genmab), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for subcutaneous treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after ≥2 lines of systemic therapy. Epcoritamab is the second T-cell-engaging bispecific antibody to become available in the US for treatment of non-Hodgkin's lymphoma; mosunetuzumab-axgb (Lunsumio) was recently approved for relapsed or refractory...

Talquetamab-tgvs (Talvey – Janssen), a bispecific GPRC5D-directed 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. Talquetamab is the first bispecific GPRC5D-directed T-cell engager to be approved in the US

Valoctocogene roxaparvovec-rvox (Roctavian – Biomarin), an adeno-associated virus (AAV) vector-based gene therapy, has been approved by the FDA for one-time treatment of severe hemophilia A in adults without pre-existing antibodies to AAV serotype 5. It is the first gene therapy to be approved in the US for treatment of hemophilia A.

Now that glucosamine and chondroitin, 2 favorite over-the-counter remedies for painful osteoarthritis (OA) of the knee, have been at least somewhat discredited, some patients will be asking about alternatives. One of these is periodic intra-articular injection of a corticosteroid or hyaluronic acid preparation.

The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

Levamisole (Janssen), an old antiparasitic drug widely used for treatment of ascariasis in animals, is now available from the National Cancer Institute (NCI) for investigational use with fluorouracil (5-FU; Adrucil; and others) as an adjuvant for treatment of resectable colon cancer that has metastasized to regional lymph nodes (Dukes stage C).

An intranasal formulation of the corticosteroid budesonide (Rhinocort Nasal Inhaler - Astra) was recently approved by the US Food and Drug Administration for treatment of seasonal or perennial allergic rhinitis in adults and children and nonallergic perennial rhinitis in adults. Budesonide has been available in Canada and Europe for several years for inhalation treatment of both allergic rhinitis and asthma.

A cyclosporine 0.05% ophthalmic emulsion (Restasis - Allergan) has been approved by the FDA for use in patients with dry eye disease (keratoconjunctivitis sicca). This review begins with a discussion of the causes of dry eye disease and includes sections on the pharmacology, adverse effects and clinical trial results for ophthalmic cyclosporine. Cost information and recommendations for administering the drug are also presented. The review concludes with an overall assessment of the drug's efficacy, safety and cost.

Our May 24, 2004 article on use of the immune response modulator imiquimod (Aldara) for treatment of actinic keratoses stated that no systemic effects have been detected. A physician reader objected, stating that he had developed fatigue while using the cream and had heard from dermatologists that other patients had also reported systemic effects.

Difelikefalin (Korsuva – Vifor), an IV kappa opioid receptor (KOR) agonist, has been approved by the FDA for treatment of moderate to severe pruritus associated with chronic kidney disease (CKD) in adults on hemodialysis. It is the first drug to be approved for this indication and the first KOR agonist to become available in the US. Difelikefalin has not been studied in patients on peritoneal dialysis.