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.
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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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