Pharmaceutical International News - May 2011
Pancreatic Cancer Treatment Drug Afinitor Approved
Posted by Pharmaceutical International's Drug Development Correspondent on 09/05/2011 - 13:00:00
The US Food and Drug Administration has formally approved a new pancreatic cancer treatment drug optimised for patients with an especially uncommon version of the condition.
According to the drug's manufacturer, it's the first new FDA approval for a drug of this kind for close to three decades and it follows the generally positive reaction that the administration's panel gave it earlier in the year.
All panel members voted for its use to treat advanced pancreatic neuroendocrine tumour patients, while noting that it could produce significant side effects which include mouth ulcers, rashes, fatigue and diarrhea.
Pancreatic Cancer Treatment Drug
The pancreatic cancer treatment drug itself is Afinitor, which is produced by Swiss firm Novartis AG and is already an approved kidney cancer treatment. Novartis, in a press release, said the approval came as a result of a Phase III clinical trial, data from which ‘...shows Afinitor delays tumor growth and reduces risk of disease progression in patients with advanced neuroendocrine tumors (NET) of pancreatic origin.'
‘This marks the first approval of a treatment for this patient population in the United States in nearly 30 years', Novartis added.
Approximately 1 person in every 300,000 will develop pancreatic neuroendocrine tumours, making them especially rare. Their development is typically slow, in contrast to other, faster pancreatic cancers that have the potential to cause death only months after first being diagnosed.
Afinitor FDA Approval
Only a limited number of treatments are available to pancreatic neuroendocrine tumour patient and, following the Afinitor FDA approval, Novartis hopes both the Swiss drug regulator and the EMA - European Medicines Agency - act similarly.
"With this approval, US physicians can now offer their patients with progressive pancreatic NET a new treatment helping to fulfil a critical unmet need", Novartis Oncology President, Hervé Hoppenot, explained in the company's press release.
"This is the third indication for Afinitor in the US in just over two years, providing further evidence that inhibiting [tumour cell booster protein] mTOR plays an important role in treating multiple tumor types."
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