Potential Steve Jobs Cancer Novartis Afinitor Treatment FDA Approved

The FDA has approved everolimus (Afinitor) for treatment of advanced pancreatic neuroendocrine tumors (pNET) that cannot be removed by surgery or that have spread to other parts of the body. Pancreatic neuroendocrine tumors are a rare form of cancer that received a lot of press when Apple Inc. founder Steve Jobs revealed that he suffers from the disease. This announcement is the first new treatment for the condition in 30 years.

Since receiving a new liver and fighting a rare form of pancreatic cancer, Mr. Jobs the co-founder and chief executive of Apple Inc., announced to his employees some time ago that he will take an indefinite leave of absence from the company to focus on his health.

Richard Pazdur, MD , director of the Office of Oncology Drug Products at the FDA stated:

"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."

The FDA's Oncologic Drugs Advisory Committee voted unanimously last month to recommend approval of the drug for pNET, which are slow-growing and rare types of tumors. It is estimated that there are fewer than 1,000 new cases in the U.S. each year, according to the FDA but treatment has been hard to come by.

Everolimus is already approved for the treatment of advanced renal cell carcinoma in patients who have received prior treatment with sunitinib or sorafenib and for the treatment of subependymal giant cell astrocytoma. It is also approved to prevent organ rejection in kidney transplant patients at low-to-moderate immunologic risk.

The safety and effectiveness of Afinitor was established a clinical trial in 410 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease. Patients in the study were selected to receive Afinitor or placebo (sugar pill). The trial was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).

Over the last 2 years, everolimus has been approved to treat several diseases by the U.S. Food and Drug Administration (FDA). The FDA first allowed the drug to be used to fight advanced kidney cancer in 2009 and gave it the go ahead for organ rejection prophylaxis and a rare form of brain cancer in 2010.

Hervé Hoppenot, president of Novartis Oncology stated:

"With this approval, U.S. physicians can now offer their patients with progressive pancreatic NET a new treatment helping to fulfill a critical unmet need. This is the third indication for Afinitor in the U.S. in just over two years, providing further evidence that inhibiting mTOR plays an important role in treating multiple tumor types."

Novartis had been seeking approval of the drug for treatment of neuroendocrine tumors that are of gastrointestinal, lung, or pancreatic origin. But, at the FDA's request, the company updated its application before the advisory panel meeting to seek approval only for treatment of tumors that begin in the pancreas.

Afinitor targets mTOR, a protein that regulates tumor cell division, blood vessel growth, and cell metabolism.

Sources: The U.S. Food and Drug Administration, Apple Inc. and Novartis

Written by Sy Kraft

Copyright: Medical News Today