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....

Tretinoin (tret' i noyn; all-trans-retinoic acid; Retin-A), a derivative of vitamin A, has been used for years for topical treatment of acne. More recently, it has also been used to improve the appearance of skin damaged by chronic exposure to the sun, although not approved for this indication by the US Food and Drug Administration.

Paclitaxel (Taxol - Bristol-Myers Squibb) is now available in the USA for treatment of metastatic ovarian cancer refractory to other drugs. The new drug is a natural product extracted in small amounts from the inner bark of the Western yew tree found mainly in the Pacific northwest (Taxus brevifolia). Efforts to synthesize the drug have been unsuccessful to date, but a semi-synthetic product (taxotere) prepared from the needles of European yews has shown some promise (R Pazdur et al, J Natl Cancer Inst, 89:1781, 1992), and a fungus (Taxomyces andreanae) growing on the Pacific yew was...

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.

The ViewPoint CK System (Refractec) for conductive keratoplasty (CK), previously approved by the FDA as a device for treatment of hyperopia (farsightedness), was recently approved for treatment of presbyopia (age-associated loss of ability to view near objects).

The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (Jevtana – Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel (Taxotere).

Three tumor necrosis factor (TNF) inhibitors – infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia) – are approved by the FDA for treatment of moderately to severely active Crohn’s disease in adults who have had an inadequate response to conventional therapy. Infliximab is also FDA-approved for the same indication in children ≥6 years old and for treatment of fistulas in adults. All 3 TNF inhibitors have been shown to reduce the signs and symptoms of Crohn's disease in clinical trials. They have been associated with adverse effects such as...

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...

The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupilumab is the first biologic drug to be approved in the US for this indication. It has been available for years for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis.