Tamoxifen, anti-estrogen used for many years in the treatment of breast cancer, has now been approved by the FDA for reducing the incidence of breast cancer in women at increased risk of developing the disease.

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 FDA has approved injection of onabotulinumtoxinA (Botox – Allergan) for prevention of headaches in adult patients with chronic migraine (≥15 headache days/month for ≥3 months). It is the first drug approved for treatment of this indication. Botox is also FDA-approved for treatment of upper limb spasticity, axillary hyperhidrosis, cervical dystonia, blepharospasm and strabismus, and for cosmetic reduction of wrinkles.

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.

Olaratumab (Lartruvo – Lilly), a platelet-derived growth factor receptor alpha (PDGFR-α) blocking monoclonal antibody, has received accelerated approval from the FDA for use in combination with the anthracycline doxorubicin for first-line treatment of adults with soft-tissue sarcoma histologic subtypes considered susceptible to anthracyclines. Approval is limited to locally advanced or metastatic soft-tissue sarcomas that are not amenable to curative radiotherapy or surgery, and is contingent on verification of clinical benefit in a confirmatory phase 3 trial.

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...

Sacituzumab govitecan-hziy (Trodelvy – Gilead) has been approved for treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in adults who received prior endocrine therapy and ≥2 additional systemic therapies for metastatic disease. It was previously approved for treatment-refractory metastatic triplenegative breast cancer and for treatment of locally advanced or metastatic urothelial cancer in adults who received platinum-based chemotherapy and a programmed death receptor-1...

Sotorasib (Lumakras — Amgen), an oral KRAS inhibitor, has received accelerated approval by the FDA for treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults who received at least one prior systemic therapy. Accelerated approval was based on the overall response rate and duration of response. KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation is the most common KRAS mutation. Sotorasib is the first KRAS inhibitor to be approved in the US.

Differin Gel 0.1% (Galderma), a topical formulation of the retinoid adapalene, will soon be available over the counter (OTC) for once-daily treatment of acne in patients ≥12 years old. It is the first topical retinoid to be approved for sale over the counter.All topical retinoids normalize keratinization and appear to have anti-inflammatory effects; whether any one topical retinoid is more effective than any other is not clear. Many dermatologists now recommend topical retinoids for first-line treatment of acne; they can be used alone or in combination with antibiotics to treat both inflamed...

Tegaserod maleate (Zelnorm), a 5-HT4 receptor partial agonist that increases gastrointestinal (GI) motility, was approved by the FDA in 2002 for short-term treatment of irritable bowel syndrome with constipation (IBS-C) in women and in 2004 for treatment of chronic idiopathic constipation (CIC) in adults <65 years old.In 2007, the manufacturer (Novartis) complied with an FDA request to stop marketing the drug based on an unpublished retrospective analysis of clinical trials in IBS-C and other GI motility disorders that showed a higher rate of ischemic cardiovascular events (including...