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Approval marks the first anti-PD-L1 therapy combination for RCC.
Bavencio (Avelumab, Pfizer) in combination with Inlyta (axitnib, Pfizer) has been approved for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This marks the first time that the FDA has approved an anti-programed death ligand-1 (PD-L1) therapy (Bavencio) in combination with a preexisting regimen (Inlyta) for patients with advanced RCC.
The combination’s approval is based upon the results of a Phase 3 JAVELIN Renal 101 study. According to a statement, the combination treatment significantly improved the median progression-free survival compared with sunitinib by more than five months in the intent-to-treat population.
Bavencio was originally approved in 2017, and is also indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel Cell Carcinoma (MCC), and patients with locally advanced or metastatic urothelial carcinoma who have either disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Inlyta, originally approved in 2012, is a kinase inhibitor indicated for the treatment of advanced RCC after the failure of one or prior systemic therapy. Starting dose for Inlyta is 5 mg once daily, swallowed whole with a glass of water, with adjustments allowable based on individual safety and tolerability. Consumptions should be taken 12 hours apart with or without food.
When indicated for RCC combination treatment with axitinib, patients should receive 800 mg of avelumab via intravenous infusion over 60 minutes, every 2 weeks, while taking 5 mg of axitinib orally twice daily.
The most common adverse events in patients with RCC while using Bavencio included diarrhea, fatigue, hypertensions, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia syndrome, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache.
The most common adverse events in patients taking Inlyta included diarrhea, hypertension, fatigue, decreased appetite, nausea, dysphonia, palmar-plantar erythrodysesthesia syndrome, weight loss, vomiting, asthenia, and constipation.
Follow the links below to learn more about each respective medication