- Japanese drugmaker Eisai's kidney cancer drug last week won an expanded indication from the FDA for second line treatment of advanced renal cell carcinoma (RCC) in combination with a chemotherapy agent.
- Lenvima (lenvatinib), a multiple receptor tyrosine kinase inhibitor, was approved for treatment of refractory differentiated thyroid cancer in February of last year.
- Approval for the RCC indication is based on phase 2 data showing significant improvements in progression-free survival, overall survival, and objective response rate.
In a phase 2 trial, treatment with Lenvima plus the chemotherapy everolimus resulted in a median progression free survival time of 14.6 months, compared with 5.5 months for those treated with everolimus alone. Objective response rates showed a similarly substantial improvement, with a 37% rate for patients treated with the combo, versus a 6% rate for patients treated just with everolimus.
The combination treatment had a safety profile comparable to similar types of drugs, with renal failure, dehydration, and anemia as the most common serious adverse events.
"Lenvatinib plus everolimus is the first and only FDA-approved regimen that successfully combines treatments that employ tyrosine kinase and mTOR inhibition, the primary targets of advanced RCC treatment for the past decade," said Robert Motzer, the principal investigator of the phase 2 study.
Approval was granted based on the strength of the phase 2 results and Eisai plans to pursue further indications for Lenvima, including in hepatocellular carcinoma.
Lenvima generated roughly $80 million in U.S. revenues since its launch in February 2015. Globally, the drug pulled in $257 million. A broader indication should help drive sales growth in the U.S.