(Med Lett Drugs Ther 2008; 50:94) In Table 1, "Invasive" should be "less" and "more" rather than "no" and "yes" for CT colonography and colonoscopy, respectively. In the conclusion, CT colonography should be changed to "less invasive" rather than "noninvasive".

The FDA has approved the marketing of an extended-release formulation of trazodone (Oleptro – Angelini Labopharm) for treatment of major depressive disorder in adults. Immediate-release trazodone has been available for treatment of depression for many years, but is used mostly in low doses for its sedating effects.

The FDA has approved Tekamlo (Novartis), an oral fixed-dose combination of the direct renin inhibitor aliskiren (Tekturna) and the calcium channel blocker amlodipine (Norvasc, and others), for treatment of hypertension in patients not adequately controlled on monotherapy or already taking both drugs, and as initial therapy in those likely to need multiple drugs to control their blood pressure (BP). Both aliskiren and amlodipine are available in combinations with other antihypertensive agents.

The FDA has approved an oral solution of the nonselective beta-adrenergic blocker propranolol (Hemangeol – Pierre Fabre) for treatment of proliferating infantile hemangiomas.

Enfortumab vedotin-ejfv (Padcev – Astellas), a nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for use with the immune checkpoint inhibitor pembrolizumab (Keytruda) for treatment of locally advanced or metastatic urothelial cancer in adults who are ineligible for cisplatin-containing chemotherapy. Accelerated approval was based on tumor response rates and the durability of response.

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 oral kinase inhibitor osimertinib (Tagrisso – AstraZeneca), which has been available for years for treatment of non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, has now been approved for treatment of unresectable stage III EGFR-mutated NSCLC. About 20-30% of patients with NSCLC have locally advanced stage III NSCLC, and 60-90% of these patients have unresectable disease. Osimertinib is the first targeted therapy to be approved for the new indication.

The U.S. Advisory Committee on Immunization Practices has recommended administration of the quadrivalent conjugated polysaccharide meningococcal vaccine (Menactra – Sanofi Pasteur) to all persons 11 to 18 years old, particularly those entering high school and college freshmen living in dormitories.1,2 The peak incidence of meningococcal disease, after early childhood, occurs in the 15-19 year-old age group. The conjugate vaccine is more immunogenic than the meningococcal capsular polysaccharide vaccine (Menommune – Sanofi Pasteur).ADVERSE EFFECTS — The most common adverse reactions with...

An extended-release oral formulation of guanfacine hydrochloride (Intuniv – Shire), a selective alpha_2A-adrenergic agonist, has been approved by the FDA for treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6-17 years old.

The Medical Letter recently reviewed a topical gel formulation of testosterone (Fortesta) for treatment of hypogonadism in men. A topical testosterone replacement product for application to the axilla, Axiron (Lilly) solution, has now become available for the same indication. This site of application presumably minimizes the risk of transferring the drug to a family member or sexual partner.