The most commonly reported adverse events (all grades; >10% patients) in the study included, stomatitis, anorexia, fatigue, rash, nausea, edema peripheral, thrombocytopenia, diarrhea, pruritus, anemia, dysgeusia, vomiting, pyrexia, pneumonitis, constipation and insomnia. Serious adverse events (grade 3 or 4; >3% of patients) included anemia, hyponatremia, raised liver function, fatigue, stomatitis, anorexia, hyperglycemia, hypophosphatemia, ileus and lymphopenia.
RAD001, an oral once-daily inhibitor of mTOR, is an investigational drug being studied in multiple tumor types. In cancer cells, RAD001 provides daily inhibition of mTOR, a protein that acts as a central regulator of tumor cell division, cell metabolism and blood vessel growth.
RAD001 is being studied in multiple cancer types including advanced kidney, breast and neuroendocrine tumors and lymphoma. Currently, RAD001 is under regulatory review in the US and Europe for the treatment of advanced renal cell carcinoma.
The safety and efficacy profile of RAD001 has not yet been established in oncology and there is no guarantee that RAD001 will become commercially available for oncology indications. The active ingredient in RAD001 is everolimus, which is available in different dosage strengths under the trade name Certican(R) for the prevention of organ rejection in heart and kidney transplant recipients. Certican was first approved in the EU in 2003. Certican is not approved in the US.
The foregoing release contains forward-looking statements that can be identified by terminology such as "promising," "will," "potential," "may," "committed," "exploring," "believed," "e
|SOURCE Novartis Pharmaceuticals Corporation|
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