Avelumab, pembrolizumab indications expanded
medwireNews: The FDA has expanded approvals to include the use of avelumab for locally advanced or metastatic urothelial carcinoma and for pembrolizumab in patients with treatment-naïve metastatic nonsquamous non-small-cell lung cancer (NSCLC).
The programmed death ligand 1 (PD-L1) inhibitor avelumab, recently given approval for metastatic Merkel cell carcinoma, may now be given to patients with urothelial carcinoma that has progressed during platinum-based chemotherapy or within a year of receiving a platinum-containing neoadjuvant or adjuvant regimen.
The accelerated approval recommends a 60-minute intravenous infusion of avelumab 10 mg/kg every 2 weeks, and states that patients should be given an antihistamine and acetaminophen before treatment for the first four infusions.
Pembrolizumab may now be given alongside pemetrexed and carboplatin for nonsquamous NSCLC patients who have not previously received treatment for metastatic disease.
The programmed cell death 1 inhibitor was previously approved by the FDA for a number of NSCLC indications, including treatment-naïve metastatic disease with high PD-L1 expression and no EGFR or ALK aberrations, and metastatic PD-L1-positive NSCLC patients who have progressed on or after platinum-based chemotherapy.
The latest accelerated approval and priority review status for pembrolizumab are based on overall response rate and progression-free survival results from the KEYNOTE-021 trial; the recommended dosage follows the trial’s use of 200 mg infusion given every 3 weeks.
Further results for the use of pembrolizumab plus chemotherapy are required to confirm the clinical benefit, the FDA says.
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