FDA grants priority review to Keytruda-Lenvima combination for kidney, endometrial cancers
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The FDA granted priority review to pembrolizumab plus lenvatinib for treatment of advanced renal cell carcinoma and advanced endometrial carcinoma, according to the agents’ manufacturers.
Pembrolizumab (Keytruda, Merck) is an anti-PD-1 therapy, and lenvatinib (Lenvima, Eisai) is a multiple receptor tyrosine kinase inhibitor.
The applications seeking approval of the combination for advanced renal cell carcinoma are based on results of the randomized phase 3 CLEAR study, presented at this year’s Genitourinary Cancers Symposium and published in The New England Journal of Medicine.
As Healio previously reported, the combination of lenvatinib and pembrolizumab improved OS, PFS and objective response rate compared with sunitinib (Sutent, Pfizer) among previously untreated patients with advanced renal cell carcinoma.
The FDA is expected to make a decision on approval for this indication by the end of August.
A second set of applications seek approval of the combination for women with advanced endometrial carcinoma who experienced disease progression after systemic therapy in any setting and are not candidates for curative surgery or radiation. These applications are based on data from the randomized phase 3 KEYNOTE-775/Study 309 trial, presented at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
As Healio previously reported, the pembrolizumab-lenvatinib combination improved OS, PFS and objective response rate compared with investigator’s choice of chemotherapy in this population.
The FDA is expected to make a decision about this indication by Sept. 3.
“Advanced renal cell carcinoma and advanced endometrial carcinoma are aggressive cancers, and patients urgently need new treatment options that may help improve outcomes,” Gregory Lubiniecki, MD, vice president of oncology clinical research with Merck Research Laboratories, said in a company-issued press release. “We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of Keytruda plus Lenvima in these patients by granting priority review for these applications.”
Merck and Eisai are evaluating the pembrolizumab-lenvatinib combination for 14 tumor types, including melanoma, hepatocellular carcinoma, non-small cell lung cancer, colorectal cancer, glioblastoma, pancreatic cancer and triple-negative breast cancer.
“We are pleased that the FDA has granted priority review for Keytruda plus Lenvima — both in advanced renal cell carcinoma and advanced endometrial carcinoma — underscoring the potential significance of the outcomes observed in the CLEAR study ... and KEYNOTE-775/Study 309 trials,” Takashi Owa, PhD, chief medicine creation officer and chief discovery officer for Eisai’s oncology business group, said in the release. “Many patients are still in need of new and effective therapies, which fuels our commitment to advancing the development of this combination even more.
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