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A drug used to attack cell growth has been found to prolong the life of patients with kidney cancer after standard therapy has failed, according to a study.
Research from Dr Bernard Escudier of the Institut Gustave Roussy, in France, showed that the inhibitor rapamycin (mTOR) – formerly known as RAD001 – is effective against metastatic renal cell cancer.
The study, presented at the Annual Congress of the European Society of Medical Oncology, looked at 410 patients with metastatic renal cell carcinoma who had failed treatment with tyrosine kinase inhibitors sorafenib or sunitinib or both agents. The study was split into two groups – one receiving RAD001 10mg/d plus best supportive care and one treated with a placebo and best supportive care.
Progression-free survival (PFS) showed a statistically significant improvement with RAD001 treatment compared with placebo. Specifically, the median PFS with RAD001 was 4.90 months versus 1.96 months for placebo, which translated into a 67% reduction in the risk of progression.
Results also showed that RAD001 significantly extended the time without tumour growth from 1.9 to four months.
In fact, the phase III trial was halted early to allow patients assigned to placebo to switch to the active drug because it had proven so effective.
RAD001 has recently been granted a priority review by the US Food and Drug Administration as treatment for advanced renal cell carcinoma. A marketing authorisation application has also been filed with the European Medicines Agency.
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“RAD001 sounds so promising. Let the US FDA approve it immediately. My son was diagnosed with kidney cancer last year and he has been through IL2, Nexavar and Sutent. He is doing well but we are hoping for the use of Everolimus to be approved. Please encourage FDA’s quick approval before it is too late.” – Barbara Vanderslice, California, USA