Breaking News

Eisai’s Lenvatinib Gains Priority Review

January 18, 2016

For the potential treatment of unresectable advanced or metastatic renal cell carcinoma

Eisai’s sNDA for lenvatinib has been accepted for Priority Review by the FDA for the potential treatment of unresectable advanced or metastatic renal cell carcinoma (RCC) in combination with everolimus following one prior vascular endothelial growth factor (VEGF)-targeted therapy. The FDA had previously granted lenvatinib Breakthrough Therapy designation for this indication.
 
Priority Review is intended for drugs that treat serious conditions and, if approved, would provide a significant improvement in safety or effectiveness. The prognosis for patients with advanced renal cell carcinoma is poor and additional treatment options are needed.
 
Lenvatinib is a multiple receptor tyrosine kinase inhibitor sold as LENVIMA, and is indicated for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC).
blog comments powered by Disqus
  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments

  • The Role of Alliances in Modern Drug Development

    The Role of Alliances in Modern Drug Development

    Dr. Claire Madden-Smith, Senior Vice President, Juniper Pharma Services||September 8, 2016
    Combining expertise to get drug candidates through development

  • Successful Method Transfer of Solid Oral Dosage

    Successful Method Transfer of Solid Oral Dosage

    John Frankonis, Ropack Pharma Solutions||June 2, 2016
    The three steps outlined will help guide the process of completing a successful analytical method transfer