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Cancer drug form Novartis approved for pancreatic tumor treatment
By jeremyc | June 14, 2011
Afinitor (everolimus), the cancer drug from Novartis, have been approved by the Food and Drug Administration (FDA) of the United States for the treatment of progressive pancreatic neuroendocrine tumors. Such tumors are usually metastasized and it is not possible to remove them through surgery. Though it is rare in occurrence—the strike rate is 0.32 cases per 100,000 people— and progresses slowly the limited treatment options have made this type of pancreatic cancers quite dreaded. With the new approval, patients as well as doctors across the world are sure to heave a sigh of relief.
Richar Pazdur, director, Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA, said, “Patients with this cancer have few effective treatment options. Afinitor has demonstrated the ability to slow the growth and spread of neuroendocrine tumors of the pancreas.”
To determine the effectiveness of Afinitor in the treatment of progressive pancreatic neuroendocrine tumors, a clinical trial was conducted with 410 participants. All the participants had locally advanced or late-stage tumors. The participants were randomly chosen and assigned placebo or Afinitor. The aim was to find out if Afinitor increased progression-free survival among the patients. It was found that the median progression-free survival among the patients who were given placebo was 4.6 months. However, the same for the patients who were assigned Afinitor was 11 months.
Even though the advisory panel has unanimously chosen Afinitor as the preferred drug for the treatment of the tumors in question there are concerns regarding the various side effects of the drug, many of which are serious in nature. Some of the side effects of the drug are rash, fatigue, stomatitis, nausea, diarrhea, abdominal pain, edema, headache and fever.
Presently Afinitor is approved for the treatment of advanced renal cell carcinoma (especially when treatment with sunitinib and sorafenib fail to bring the desired results) and subependymal giant cell astrocytoma associated with tuberous sclerosis (when surgery cannot be performed). On the other hand, Zortress, another trade name for Afinitor, is approved for the prevention of organ rejection following a kidney transplant.
Following the FDA approval for the treatment of progressive pancreatic neuroendocrine tumors, Novartis released a statement that said, “Data show Afinitor delays tumour growth and reduces risk of disease progression in patients with advanced neuroendocrine tumours (NET) of pancreatic origin. This marks the first approval of a treatment for this patient population in the United States in nearly 30 years.”
Topics: | Cancer |
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