The US Food and Drug Administration (FDA) approved several drugs in March 2022 relevant to conditions often treated by nurse practitioners and PAs. Approvals include treatments for endometrial carcinoma, metastatic melanoma, and a transdermal patch for Alzheimer disease.
Adlarity® for Alzheimer Disease
The FDA has approved Adlarity® (donepezil transdermal patch) for the treatment of mild to severe dementia of the Alzheimer type. Each patch administers either 5 mg or 10 mg of donepezil daily for 7 days, after which it is removed and replaced with a new patch.
Approval was based on a relative bioavailability study in which donepezil exposure from once weekly Adlarity transdermal patch was comparable with that from daily donepezil tablets (10 mg/d) in healthy patients. The adhesion of the transdermal system was evaluated in 85 patients. Results indicated that 91% of patches exhibited 80% or greater surface area adhesion.
The most common adverse reactions reported include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia. Reactions at the application site also have been reported.
Keytruda® for Endometrial Carcinoma
Keytruda® (pembrolizumab) was approved by the FDA as a single agent to treat patients with advanced endometrial carcinoma that is either microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Patients must have disease progression following prior systematic therapy and not be candidates for surgery or radiation.
Approval was based on data from the open-label, multicohort phase 2 KEYNOTE-158 trial that evaluated Keytruda in patients with multiple types of advanced solid tumors. Every 3 weeks, patients received 200 mg of Keytruda until unacceptable toxicity or documented disease progression.
Based on a median follow-up time of 16 months, results showed an objective response rate of 46% (95% CI, 35-56) among the 90 patients, with 12% achieving complete response and 33% achieving partial response. The median duration of response was not reached (95% CI, 2.9-55.7+ months), with 68% of patients having a response duration of at least 12 months and 44% having a response duration of at least 24 months.
The most common adverse reactions reported were fatigue, musculoskeletal pain, rash, diarrhea, pyrexia, cough, decreased appetite, pruritus, dyspnea, constipation, pain, abdominal pain, nausea, and hypothyroidism.
Opdualag™ for Unresectable Metastatic Melanoma
The FDA has approved Opdualag™ (nivolumab and relatlimab-rmbw) for the treatment of patients 12 years and older with unresectable metastatic melanoma. Opdualag is a combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody.
Approval was based on data from a randomized, double-blind phase 2/3 study that evaluated the safety and efficacy of Opdualag in 714 participants diagnosed with untreated metastatic or unresectable stage III or IV melanoma. Treatment with Opdualag was associated with a statistically significant improvement in progression-free survival compared with nivolumab (hazard ratio [HR], 0.75; 95% CI, 0.62-0.92; P =.0055).
The most common adverse reactions included musculoskeletal pain, fatigue, rash, pruritus, and diarrhea.
Opdualag is supplied in a single-dose vial as 240 mg of nivolumab and 80 mg of relatlimab per 20 mL.
Ztalmy® for Seizures Associated With CDKL5 Deficiency Disorder
Ztalmy® (ganaxolone)was approved by the FDA for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years and older. This genetic disorder leads to the difficulty in controlling seizures and neurodevelopmental display.
The approval was based on data from the randomized, placebo-controlled, double-blind phase 3 Marigold study that evaluated the safety and efficacy of Ztalmy in 101 patients (2 to 19 years old) with CDKL5 gene mutation. Results indicated that Ztalmy treatment was associated with a 30.7% median reduction in 28-day motor seizure frequency compared with a 6.9% reduction with placebo (P =.0036).
The most common adverse reactions reported were somnolence, pyrexia, salivary hypersecretion, and seasonal allergy. Ztalmy is supplied as a 135-mL bottle with 50 mg/mL of ganaxolone oral suspension in a carton of 1 or 5 bottles.
Adlarity. Package insert. Corium, Inc.; 2022. Accessed March 24, 2022. https://www.corium.com/products/ADLARITY/ADLARITY_PI_ENGLISH_US.pdf
Keytruda. Package insert. Merck & Co., Inc.; 2022. Accessed March 24, 2022. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf
Opdualag. Prescribing infromation. Bristol-Myers Squibb; 2022. Accessed March 24, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761234s000lbl.pdf
Ztalmy. Prescribing information. Marinus Pharmaceuticals, Inc.; 2022. Accessed March 24, 2022. https://marinuspharma.com/wp-content/uploads/2022/03/prescribing-information.pdf