FDA granted Priority Review to lenvatinib for the treatment of patients with unresectable advanced or metastatic renal cell carcinoma in combination with everolimus following one prior vascular endothelial growth factor-targeted therapy. FDA previously granted lenvatinib Breakthrough Therapy designation for this investigational indication. “With the FDA’s acceptance of this supplemental application, we are one step closer...
In two back-to-back, all-day meetings, the FDA Oncologic Drugs Advisory Committee considered four thorny applications that the agency appeared to have been saving up as a result of the pause in activity that followed President Trump’s return to office.
