FDA Approves Lenvima for Treatment of Progressive Radioiodine-refractory Differentiated Thyroid Cancer (RR-DTC)

Innovation That Matters
Thyroid Cancer

FDA announced this February the approval of lenvima (lenvatinib), a novel investigative chemotherapy for patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC).  Lenvima is developed by Eisai Co., Ltd headquartered in Tokyo, Japan.  This approval is one day after the publication of Eisai’s phase III multi-nation clinical trial in the New England Journal of Medicine (NEJM), which showed significant progression-free survival (PFS) in lenvima group compared to placebo control group (median PFS 18.3 months with lenvima vs. 3.6 months with placebo).

Differentiated thyroid cancer is the most common type of thyroid cancer representing about 95% of all thyroid cancers.  Some of differentiated thyroid cancers are radioiodine-refractory (RR-DTC) and treatment options for this group of patients are limited, which presents a significant unmet medical need.  Eisai’s lenvima is an oral RTK (receptor tyrosine kinase) inhibitor selectively targeting multiple different molecules including VEGFR, FGFR, RET, KIT and PDGFR, some of which are involved in tumor angiogenesis and proliferation of thyroid cancer.

Lenvima was granted Orphan Drug Designation for thyroid cancer by regulatory authorities in Japan, the United States and Europe.  In addition, Lenvima was granted priority review status in the United States and accelerated assessment in Europe.  Currently Eisai is conducting several trials of lenvima attempting to treat several solid tumors, including hepatocellular carcinoma, renal cell carcinoma and non-small cell lung cancer.  Depending on the results of these trial, lenvima could become an oncology blockbuster.


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