The FDA has approved the oral multikinase inhibitor lenvatinib (Lenvima – Eisai) for treatment of locally recurrent or metastatic, progressive, differentiated thyroid cancer (papillary or follicular) refractory to radioactive iodine treatment.

The FDA has approved a once-daily, extended-release chewable tablet formulation of methylphenidate (QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first long-acting chewable formulation of the drug to be marketed in the US. Immediate-release chewable methylphenidate tablets (Methylin, and generics) have been available since 2003.

The FDA has approved an extended-release intramuscular suspension formulation of the gonadotropin-releasing hormone (GnRH) agonist triptorelin (Triptodur – Arbor/Debiopharm) for twice-yearly treatment of central precocious puberty (CPP) in children ≥2 years old. Triptorelin has been available in the US for years as Trelstar for palliative treatment of advanced prostate cancer. Before the approval of Triptodur, Trelstar was used off-label for treatment of CPP.

Fensolvi (Tolmar), a long-acting subcutaneous formulation of the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate, has been approved by the FDA for treatment of central precocious puberty (CPP) in children ≥2 years old. It is the first formulation of the drug to be approved for SC administration once every 6 months. IM formulations of leuprolide acetate, which are given once monthly or every 3 months, and the GnRH agonists histrelin acetate (Supprelin LA) and triptorelin (Triptodur) have been available for years for treatment of CPP.

The FDA has approved Opill (Perrigo), a progestin-only oral contraceptive that contains norgestrel, for sale over the counter (OTC). Opill is the first oral contraceptive to be approved in the US for sale without a prescription. Approval of OTC Opill is intended to increase access to effective contraception and reduce the rate of unintended pregnancies.

Betibeglogene autotemcel (Zynteglo — Bluebird Bio), an autologous lentiviral vector cell-based gene therapy, has been approved by the FDA for one-time treatment of transfusion-dependent beta thalassemia in children and adults. Exagamglogene autotemcel (Casgevy), a cell-based gene therapy that uses CRISPR/Cas9 gene-editing technology, was approved earlier this year for the same indication in patients ≥12 years old.

The FDA has approved imetelstat (Rytelo – Geron), a first-in-class telomerase inhibitor, for treatment of low- to intermediate-1 risk myelodysplastic syndromes (MDS) in adults with transfusion-dependent anemia requiring 4 or more red blood cell (RBC) units over 8 weeks who have not responded to, are no longer responding to, or are ineligible for erythropoiesis-stimulating agents (ESAs).

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The recent terrorist attacks on the US have led to many questions about the clinical effects, prevention and treatment of injury caused by chemical warfare agents.

The FDA has approved an oral tablet formulation of sodium sulfate, magnesium sulfate, and potassium chloride (Sutab – Braintree) for colon cleansing prior to colonoscopy in adults. A sodium sulfate-based oral solution (Suprep) has been available in the US since 2010. Sutab is the second tablet formulation to be approved for bowel cleansing prior to colonoscopy; a sodium phosphate-based tablet (OsmoPrep) was approved earlier.