publication date: Feb. 20, 2015

FDA Approves Lenvima In Metastatic Thyroid Cancer

 

FDA approved Lenvima (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. Lenvima was approved following a priority review.

Lenvima demonstrated a statistically significant progression-free survival prolongation and response rate in patients with progressive, differentiated thyroid cancer who had become refractory to radioactive iodine therapy.

In the phase III SELECT trial, which included 392 patients, Lenvima demonstrated a highly statistically significant improvement in PFS in patients with RAI-R DTC compared with placebo. The median PFS with Lenvima and placebo was 18.3 months and 3.6 months, respectively (HR 0.21; 95% CI: 0.16-0.28; p<0.001).

In addition, an overall response rate of 65 percent was seen in patients treated with Lenvima versus 2 percent with placebo.

Lenvima is sponsored by Eisai Inc.

 

FDA expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma.

Revlimid plus dexamethasone was previously approved in June 2006 for use in multiple myeloma patients who have received at least one prior therapy.

The approval was based on safety and efficacy results from phase III studies, including the FIRST trial (MM-020/IFM 07-01), which evaluated continuous Revlimid in combination with dexamethasone until disease progression versus melphalan, prednisone and thalidomide for 18 months as the primary analysis, and a fixed duration of 18 cycles of Rd as a secondary analysis, in 1,623 newly diagnosed patients who were not candidates for stem cell transplant.

PFS was significantly longer for patients receiving Rd Continuous (25.5 months) than for those … Continue reading 41-07 FDA Approves Lenvima in Metastatic Thyroid Cancer

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