Novartis kidney cancer drug clears key hurdle

Everolimus (RAD001) significantly extends progression-free survival in advanced kidney cancer patients after failure of other targeted therapy  Outstanding interim results cause independent data monitoring committee to immediately share findings; patients on placebo to be offered everolimus  Everolimus (RAD001) tablet, taken once daily, demonstrated highly effective anti-tumor activity through continuous targeted inhibition of mTOR  Results of RECORD-1 trial address unmet medical need in renal cell cancer with worldwide regulatory filings planned for second half of 2008  Complete results to be submitted as late-breaking abstract for presentation at the American Society of Clinical Oncology meeting  Basel, February 28, 2008 — An independent data monitoring committee stopped a major Phase III clinical trial of the investigational drug everolimus (RAD001) today after interim results showed significantly better progression-free survival in patients with advanced kidney cancer who received everolimus compared to placebo. The committee stopped the trial of more than 400 patients conducted in 12 countries because the study met its primary endpoint. The interim findings are being shared with investigators to allow them to offer everolimus to patients remaining on placebo.  Everolimus may fulfill an unmet medical need for patients with advanced renal cell cancer (RCC) who currently have no approved treatment options. ...
Source: Kidney Cancer Association - Category: Urology & Nephrology Source Type: news