The FDA recently approved axicabtagene ciloleucel (Yescarta – Kite), a CD19-directed genetically modified cellular product, for treatment of large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line treatment. It was previously approved for treatment of relapsed or refractory B-cell lymphoma after ≥2 lines of systemic therapy and for treatment of relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells,...

The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of ocular inflammation and pain following ophthalmic surgery.

The FDA has approved lisocabtagene maraleucel (Breyanzi – BMS) for treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B who have disease refractory to first-line chemoimmunotherapy, relapsed within 12 months of or after first-line chemoimmunotherapy, are not eligible for hematopoietic stem cell transplantation due to comorbidities or age, or have relapsed or refractory disease after ≥2 lines of...

Taletrectinib (Ibtrozi – Nuvation Bio), an oral kinase inhibitor, has been approved by the FDA for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. It is the fourth oral kinase inhibitor to be approved in the US for this indication; crizotinib (Xalkori), entrectinib (Rozlytrek), and repotrectinib (Augtyro) were approved earlier.

The FDA has approved cefiderocol (Fetroja – Shionogi), a new IV cephalosporin antibiotic, for treatment of complicated urinary tract infections (UTI) caused by susceptible gram-negative bacteria in adults who have limited or no alternative treatment options.

Botulinum toxin type A has been marketed in the USA since 1989 for treatment of strabismus and blepharospasm and has also been used to treat cervical dystonia and some other muscular disorders.

Ponatinib (Iclusig – Ariad), a tyrosine kinase inhibitor, has been approved by the FDA for treatment of chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome- positive (Ph+) acute lymphoblastic leukemia (ALL) resistant to prior tyrosine kinase inhibitor therapy. It is the fifth tyrosine kinase inhibitor approved for the treatment of CML or Ph+ ALL.

Empagliflozin (Jardiance – Boehringer Ingelheim/Lilly), an SGLT2 inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. It is the third SGLT2 inhibitor to be approved for this indication.

The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.

Mirvetuximab soravtansine-gynx (Elahere – Immuno-Gen), an antibody-drug conjugate, has received accelerated approval by the FDA for treatment of folate receptor (FR) alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy. Accelerated approval was based on the overall response rate and median duration of response.