The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of extensive-stage small cell lung cancer (SCLC) in adults who had disease progression on or after platinum-based chemotherapy. It is the first bispecific DLL3-directed CD3 T-cell engager to be approved in the US for this indication. Most patients with SCLC have a response to initial treatment, but progression generally occurs within a few months and overall survival is usually less than 8 months....

Penpulimab-kcqx (Anniko – Akeso Biopharma), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin or carboplatin plus gemcitabine for first-line treatment of recurrent or metastatic nonkeratinizing nasopharyngeal carcinoma and for use as monotherapy for metastatic disease in adults with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Penpulimab is the second immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma;...

Many women of child-bearing age now take folic acid supplements of 400 ╡g per day to prevent neural tube defects in their offspring (Medical Letter 1998; 40:75). An FDA advisory committee has recommended development of a combination tablet containing an oral contraceptive and 400 ╡g of folic acid. A recent editorial in the New England Journal of Medicine suggested that folic acid doses should be higher (NJ Wald, N Engl J Med 2004; 350:101).

The Medical Letter article (Med Lett Drugs Ther 2007; 49:71) on Low-Dose Transdermal Estrogens said that Elestrin has been marketed in Europe since 1976. Actually it is EstroGel (Ascend Therapeutics), a similar product, that has been available in Europe since 1976.

The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and trametinib (Mekinist – GSK) for melanomas with either BRAF V600E or V600K mutations. Dabrafenib is not recommended for patients with wild-type BRAF (BRAF-negative) melanoma, and trametinib is not recommended for patients who have received prior BRAF-inhibitor therapy.

The FDA has approved ciltacabtagene autoleucel (Carvykti – Janssen), 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. Carvykti 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. Idecabtagene...

Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors...

The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) was approved by the FDA in 2020 to reduce the risk of cardiovascular death and hospitalization for heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF). The indication has now been expanded to include a reduction in the risk of urgent HF visits and use in adults with any left ventricular ejection fraction (LVEF).

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.