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Pembrolizumab granted priority review for three oncology indications
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The FDA granted priority review to pembrolizumab, an anti-PD-1 therapy, for three oncology indications.
The designations apply to use of pembrolizumab (Keytruda, Merck):
- as monotherapy for third-line treatment of patients with advanced small cell lung cancer whose disease progressed after two or more lines of therapy.
The FDA based the designation on data from the phase 2 KEYNOTE-158 and phase 1b KEYNOTE-028 trials. The FDA is expected to make a decision by June 17.
This is the first U.S. application for pembrolizumab for small cell lung cancer;
- as monotherapy or in combination with platinum and 5-FU chemotherapy for first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.
The FDA based this designation on OS results from the randomized phase 3 KEYNOTE-048 trial, which compared pembrolizumab alone or with EXTREME chemotherapy among 882 patients with recurrent or metastatic HNSCC. EXTREME — the standard first-line treatment — consists of the EGFR inhibitor cetuximab (Erbitux, Eli Lilly) plus carboplatin or cisplatin.
OS and PFS served as dual primary endpoints.
Median follow-up was 11.7 months for patients assigned pembrolizumab monotherapy, 13 months for those assigned pembrolizumab plus chemotherapy, and 10.7 months for those assigned EXTREME.
Pembrolizumab monotherapy prolonged OS compared with EXTREME among patients whose tumors had PD-L1 combined positive score (CPS) of 20 or higher, as well as those who had CPS of 1 or higher. The combination of pembrolizumab plus chemotherapy prolonged OS compared with EXTREME among the total patient population.
The FDA is expected to make a decision by June 10; and
- in combination with axitinib (Inlyta, Pfizer) for first-line treatment of patients with advanced renal cell carcinoma.
The application is based on findings from the phase 3 KEYNOTE-426 trial, which showed pembrolizumab plus axitinib, a tyrosine kinase inhibitor, significantly improved OS and PFS as first-line therapy in patients with advanced renal cell carcinoma compared with pembrolizumab and sunitinib (Sutent, Pfizer).
The FDA set a target action date of June 20.
For more information on these FDA actions and others, visit Healio.com/HemOnc and search for “FDA News.”