A US Food and Drug Administration (FDA) committee has recommended the use of two drugs, one developed by Novartis and the other by Pfizer, for the treatment of pancreatic cancer.
Novartis announced that the Oncologic Drugs Committee voted unanimously to back Afinitor (everolimus) tablets for patients with advanced neuroendocrine tumours of pancreatic origin.
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The panel was presented data from the Radiant In Advanced Neuroendocrine Tumours trial programme, in which patients with the disease experienced a significant improvement in progression-free survival with everolimus versus placebo.
Novartis Oncology president Hervé Hoppenot said, “We look forward to working with the FDA as it completes its review and we are encouraged by the advisory committee’s recommendation to approve everolimus for patients with advanced pancreatic neuroendocrine tumours.”
Afinitor is already approved as a treatment for advanced kidney cancer and a rare genetic disorder called tuberous sclerosis.
Separately, the committee voted 8-2 to approve Pfizer’s Sutent (sunitinib malate), an oral drug that blocks molecules involved in the growth and spread of tumours, for the treatment of neuroendocrine tumours that cannot be surgically removed.
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By GlobalDataThe panel’s advice will be considered by the FDA when finalizing its review of Pfizer’s supplemental new drug application for sunitinib for this indication.
It was approved in Europe in December last year.
