The Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa), which was previously approved by the FDA for treatment of mantle cell lymphoma, Waldenström's macroglobulinemia, and relapsed or refractory marginal zone lymphoma, has now been approved for treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults. The BTK inhibitors ibrutinib (Imbruvica) and acalabrutinib (Calquence) were approved earlier for treatment of CLL and SLL.

Topical ivermectin lotion 0.5% (Sklice, and generics), which has been available by prescription since 2012, is now FDA-approved for sale over the counter (OTC) for treatment of head lice in patients ≥6 months old. Ivermectin is also available by prescription as a 1% cream (Soolantra) approved for topical treatment of inflammatory lesions of rosacea and in oral tablets (Stromectol, and generics) for treatment of various parasitic infections.

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

The FDA has licensed the pentavalent vaccine Penmenvy (GSK) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years old. Penmenvy is the second pentavalent meningococcal vaccine to become available in the US; Penbraya was licensed in 2023.

Efgartigimod alfa-fcab (Vyvgart – Argenx), a first-in-class neonatal Fc receptor (FcRn) antagonist, has been approved by the FDA for IV treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive. The IV complement inhibitor eculizumab (Soliris) was approved for the same indication in 2017.

The FDA has approved idecabtagene vicleucel (Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, 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. Abecma is an individualized cellular product prepared from the patient’s own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. Ciltacabtagene autoleucel...

The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults who received ≥2 prior lines of systemic therapy, including a BTK inhibitor. Accelerated approval was based on the response rate. The BTK inhibitors ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa) are also approved for treatment of MCL.

Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in adults who received ≥2 lines of systemic therapy. It is the first T-cell-engaging bispecific antibody to be approved in the US for this indication.

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have been approved by the FDA for use together for a sixth indication: treatment of low-grade glioma (LGG) with a BRAF V600E mutation in patients ≥1 years old who require systemic therapy. This combination is the first systemic therapy to be approved in the US for first-line treatment of LGG with a BRAF V600E mutation in pediatric patients. The FDA also approved new oral formulations of both drugs for patients who are unable to swallow dabrafenib capsules or trametinib...