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Pharmaceutical industry

Eisai's Lenvima Receives FDA Approval for Rare Thyroid Cancer Treatment

Strategic Insights

— 1 min read

Eisai's US subsidiary, Eisai Inc., has received approval from the US Food and Drug Administration (FDA) for its anticancer agent Lenvima (lenvatinib mesylate) to treat locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). This marks the first country in the world where Lenvima has received marketing authorization. The approval was based on the results of a Phase III study, the SELECT study, which demonstrated a statistically significant extension in progression-free survival (PFS) compared to placebo. Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules, including VEGFR, FGFR, RET, KIT, and PDGFR.

Key Takeaways:

  • Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules, including VEGFR, FGFR, RET, KIT, and PDGFR.
  • The agent has been confirmed through X-ray crystal structural analysis to be the first compound to demonstrate a new binding mode (Type V) to VEGFR2.
  • Lenvima was approved based on the results of the multicenter, randomized, double-blind, placebo-controlled Phase III study (the SELECT study) of 392 patients with progressive RAI-R DTC.
  • The SELECT study demonstrated a statistically significant extension in progression-free survival (PFS) compared to placebo.
  • The approval marks the first country in the world where Lenvima has received marketing authorization.
  • Eisai will continue to file applications seeking regulatory approval for Lenvima in countries around the world.
  • Lenvima is also being studied in hepatocellular carcinoma, renal cell carcinoma, and non-small cell lung cancer.
  • There are approximately 52,000 new cases of thyroid cancer diagnosed in the US every year.

Statistics:

  • 52,000: Estimated number of new cases of thyroid cancer diagnosed in the US in 2012.
  • 392: Number of patients in the Phase III study (SELECT study) that evaluated the efficacy of Lenvima for RAI-R DTC.
  • 6 months: Timeframe from submission of the New Drug Application in August 2014 to FDA approval.
  • 2 months: Timeframe by which Eisai's Lenvima received approval two months ahead of the FDA priority review action date.
  • 2012: Year in which the estimated number of new cases of thyroid cancer was approximately 52,000.

Sources:

  • Eisai Co., Ltd. Press Release, Eisai Co., Ltd. (no date)

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