A little over one month after the US Food & Drug Administration's Oncologic Drug Advisory Committee voted 11-2 in favor of approving Votrient for the treatment of some soft- tissue sarcomas, the FDA has made it official.
Votrient (pazopanib) was previously approved in 2009, and then only for the treatment of renal cell carcinoma.
In the form of 200 mg tablets, it is now also approved for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy.
However, there is a noted limitation of use: The efficacy of this drug for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
The FDA approved Votrient for soft-tissue sarcomas based on the results of the pivotal, randomized, double-blind, placebo controlled, multi-center Phase III study known by the acronym PALETTE (PAzopanib ExpLorEd in sofT Tissue sarcoma).
Source: MarketWatch
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