Saturday, May 7, 2011

Novartis' pancreatic cancer drug Afinitor receives US FDA approval

Novartis announced that the US Food and Drug Administration (FDA) approved Afinitor (everolimus) tablets for the treatment of progressive neuroendocrine tumours of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. This marks the first approval of a treatment for this patient population in the US in nearly 30 years.

The approval was based on phase III data from the RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumours) trial showing treatment with Afinitor more than doubled the time without tumour growth (median 4.6 to 11.0 months) and reduced the risk of cancer progression by 65% when compared with placebo in patients with advanced pancreatic NET (hazard ratio=0.35 [95% confidence interval (CI), 0.27 to 0.45]; p<0.001). A consistent improvement in progression-free survival was seen with Afinitor in all patient subgroups. The FDA determined that the safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumours have not been established.

"The FDA approval of Afinitor represents an important step forward for patients with advanced pancreatic NET," said James Yao, MD, Associate Professor of Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas. "Patients will now have access to a treatment that has been shown to significantly delay tumour growth and reduce the risk of disease progression."

Approximately 60% of pancreatic NET patients are diagnosed with advanced disease. This means that the cancer has already spread to other parts of the body, and is considered aggressive and difficult to treat. The five-year survival rate for these patients is 27%.

"With this approval, US physicians can now offer their patients with progressive pancreatic NET a new treatment helping to fulfil a critical unmet need," said Hervé Hoppenot, president, Novartis Oncology. "This is the third indication for Afinitor in the US in just over two years, providing further evidence that inhibiting mTOR plays an important role in treating multiple tumour types."

Afinitor targets mTOR, a protein that acts as an important regulator of tumour cell division, blood vessel growth and cell metabolism. Preclinical and clinical data have established the role of mTOR in the development and progression of several types of tumours, including advanced pancreatic NET.

Novartis has submitted marketing applications for everolimus for the treatment of patients with advanced NET of gastrointestinal, lung or pancreatic origin to the European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products (Swissmedic), and additional regulatory submissions are being reviewed by health authorities worldwide.

Neuroendocrine tumours arise from cells that can produce and secrete a variety of hormones that regulate bodily functions. These tumours can occur anywhere in the body; however, most are found in the pancreas (pancreatic NET), gastrointestinal tract or lungs (carcinoid tumours). Pancreatic NET, also known as islet cell tumours, is a rare type of cancer different from pancreatic exocrine cancer, which is generally referred to as pancreatic cancer. There have been limited treatment options for patients with pancreatic NET.

RADIANT-3 is a phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of Afinitor plus best supportive care (BSC) versus placebo plus BSC in 410 patients with advanced, low- or intermediate-grade pancreatic NET. Patients who met the study entry criteria were randomized 1:1 to receive either Afinitor 10 mg once-daily (n=207) or daily placebo (n=203) orally, both in conjunction with BSC.

The primary endpoint of RADIANT-3 is progression-free survival. Secondary endpoints include safety, objective response rate (confirmed according to RECIST), duration of response and overall survival.

Afinitor (everolimus) tablets is approved in the US for the treatment of progressive neuroendocrine tumours of pancreatic origin in patients with unresectable, locally advanced or metastatic disease. The FDA determined that the safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumours have not been established.

Afinitor is approved in the European Union (EU) for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy and also in the US for the treatment of patients with advanced RCC after failure of treatment with sunitinib or sorafenib.

Afinitor is also approved in the US to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of Afinitor is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been shown. Novartis has submitted marketing applications for everolimus for this use to the European Medicines Agency (EMA) and the Swiss Agency for Therapeutic Products (Swissmedic), and additional regulatory submissions are under way worldwide.

In the EU, everolimus is available in different dosage strengths for the non-oncology patient population under the trade name Certican for the prevention of organ rejection in heart and kidney transplant recipients. In the US, everolimus is available in different dosage strengths under the trade name Zortress for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.

Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Source: Pharmabiz

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