Isatuximab-irfc (Sarclisa – Sanofi), a CD38-directed cytolytic antibody, has been approved by the FDA for treatment of newly diagnosed multiple myeloma in adults who are not eligible for autologous stem cell transplantation (ASCT). The drug was approved earlier for treatment of relapsed or treatment-refractory multiple myeloma.

Zolbetuximab-clzb (Vyloy – Astellas), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, has been approved by the FDA for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in patients who have CLDN18.2-positive tumors. It is the first monoclonal antibody to be approved in the US that selectively targets CLDN18.2.

The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate- and extended-release formulations of the acetylcholinesterase inhibitor galantamine have been available in the US for years for treatment of AD.

Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause worsening functional limitation or severe morbidity. The kinase inhibitor pexidartinib (Turalio) was approved for a similar indication in 2019.

Telisotuzumab vedotin-tllv (Emrelis – Abbvie), a c-Met-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining] who received prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response.

Dordaviprone (Modeyso – Jazz), an oral protease activator, has received accelerated approval from the FDA for treatment of diffuse midline gliomas harboring a H3 K27M mutation in patients ≥ year old who had disease progression following prior treatment. It is the first drug to be approved in the US for this indication.

The FDA has requested the removal of some boxed warnings from the labels of vaginal and systemic menopausal hormone therapy (MHT) products. The warnings were initially added in 2003 based on the results of two placebo-controlled Women's Health Initiative (WHI) trials evaluating the use of systemic hormones for primary prevention of coronary heart disease (CHD) in postmenopausal women 50-79 years old.

The FDA has approved the interleukin-2 (IL-2) receptor-directed fusion protein denileukin diftitox (Lymphir – Citius) for treatment of relapsed or refractory stage I-III cutaneous T-cell lymphoma in adults who received at least one prior systemic therapy. Lymphir is a reformulated, purified version of Ontak, which was voluntarily withdrawn from the market in 2014 because of manufacturing issues.

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 Viekira Pak (Abbvie), a fixed-dose combination of two new direct-acting antiviral agents (ombitasvir, paritaprevir) with the pharmacologic enhancer ritonavir in one tablet, co-packaged with a third new direct-acting antiviral agent (dasabuvir) in a second tablet, for oral treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Genotype 1 is responsible for 70-80% of HCV infections in the US.