Updates from FDA
New Drugs
MOBOCERTINIB
(Exkivity—Takeda Pharmaceuticals)
Drug class: Kinase inhibitor.
Indication: Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Recommended dosage and administration: Supplied as 40 mg capsules. Dosing is 160 mg, by mouth, once daily until disease progression or unacceptable toxicity. Exkivity can be taken with or without food. If vomiting occurs, the dose should not be repeated.
Common adverse effects: Adverse effects with incidence greater than 20% include diarrhea, rash, nausea, painful swelling and sores in mouth, vomiting, decreased appetite, nail inflammation, fatigue, dry skin, and musculoskeletal pain.
Boxed warning: Increased risk of QTc prolongation and Torsade de Pointes. QTc and electrolytes should be monitored at baseline and periodically during treatment. Patients should avoid concomitant use of other drugs known to prolong QTc interval or drugs which are moderate to strong CYP3A inhibitors.
Other warnings and precautions: Interstitial lung disease, pneumonitis, cardiac toxicity, embryo-fetal toxicity.
ATOGEPANT
(Qulipta—AbbVie)
Drug class: Calcitonin gene-related peptide receptor antagonist.
Indication: Preventative treatment of episodic migraines.
Recommended dosage and administration: 10 mg, 30 mg, or 60 mg taken orally once daily with or without food. There is no recommendation on which dose should be started as the initial dose or when a dose should be titrated up or down. Dose modifications are recommended for patients who are concomitantly taking medications that are strong CYP3A4 inhibitors or inducers, OATP inhibitors, and patients with renal impairment.
Common adverse effects: Nausea, constipation, fatigue.
Warnings and precautions: None noted.
New Biosimilars
RANIBIZUMAB-NUNA
(Byooviz—Biogen)
Drug class: Vascular endothelial growth factor (VEGF) inhibitor.
Indications: Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. Note: Byooviz is an FDA-approved biosimilar to the reference product Lucentis. However, it has not received approval to be interchangeable with the reference product.
Recommended dosage and administration: 0.5 mg (0.05 mL) administered by intravitreal injection once every 28 days. Duration of treatment depends on indication—see full prescribing information for more information.
Common adverse effects: Increased intraocular pressure.
Warnings and precautions: Increased risk of infections inside the eye and retinal detachment—proper aseptic injection technique should be used when administering Byooviz. Potential risk of arterial thromboembolic events (e.g., nonfatal stroke, nonfatal myocardial infarction, vascular death).
New indications
CABOMETYX
(Cabozantinib—Exelixis)
Drug class: Kinase inhibitor.
Indications: Cabometyx has been previously approved for treatment of patients with advanced renal cell carcinoma and patients with hepatocellular carcinoma who have been previously treated with sorafenib. In September 2021, it received approval for use in patients 12 years and older with locally advanced or metastatic differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy and who are refractory to or ineligible for radioactive iodine.
Recommended dosage and administration: General dosing for adults is 60 mg once daily until disease progression or unacceptable toxicity. For patients aged 12 to 18 years with a body surface area less than 1.2 m2, dose is 40 mg once daily.
Dose may vary based on type of cancer, other drug therapy, or adverse reactions. See full prescribing information for details. Cabometyx should not be taken with food—patient should take the dose at least 1 hour before a meal or 2 hours after a meal. Cabometyx tablets should not be crushed. Dose modifications may be necessary when administered with other medications that are metabolized through CYP3A enzymes.
Common adverse effects: Adverse effects with incidence greater than 20% include diarrhea, fatigue, palmar-plantar erythrodysesthesia, decreased appetite, hypertension, nausea, vomiting, weight decrease, and constipation.
Warnings and precautions: Extensive warnings and precautions—see full prescribing information for entire list.
New formulations
DIHYDROERGOTAMINE MESYLATE
(Trudhesa—Impel NeuroPharma)
Drug class: Ergotamine derivative.
Indication: Acute treatment of migraine (with or without aura).
Recommended dosage and administration: Trudhesa is a nasal spray that employs a proprietary delivery technology. The recommended dosing is 1.45 mg and is divided into 2 metered sprays—one in each nostril. Patients can repeat the dose 1 hour after initial dose, if needed, for a maximum of 2 doses in 24 hours or 3 doses in 7 days.
Use is contraindicated in patients who are also taking strong CYP3A4 inhibitors, patients with ischemic heart disease, patients with uncontrolled hypertension, patients with hypersensitivity to ergot alkaloids, patients who are also taking other 5-HT1 agonists, and patients who are also taking peripheral and central vasoconstrictors.
Common adverse effects: Adverse effects with incidence greater than 1% include rhinitis, nausea, altered sense of taste, application site reactions, dizziness, vomiting, excessive sleepiness, pharyngitis, and diarrhea.
Warnings and precautions: Risk of myocardial ischemia and/or infarction and other cardiovascular events—consider administering first dose in a health care setting in patients with risk factors. Risk of cerebral hemorrhage, subarachnoid hemorrhage, vasospasm, and increased blood pressure—monitor for signs or symptoms and discontinue if any develop. Risk of medication overuse headache. Risk of preterm labor in pregnant women. Prolonged daily use may lead to pleural and retroperitoneal fibrosis—patients should not exceed recommended dosing.