Pfizer's Sutent Approved By FDA For Treating Rare Type Of Pancreatic Cancer

The U.S. Food and Drug Administration today approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).

Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.

This is the second new approval by the FDA to treat patients with this disease; on May 5, the agency approved Afinitor (everolimus).

“FDA believes it is important to provide cancer patients with as many treatment options as possible,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to working with companies to bring innovative new therapies to the market and encourages companies to continue exploring additional uses for approved products.”

The safety and effectiveness of Sutent was established in a single study of 171 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease who received Sutent or a placebo (sugar pill). The study was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).

Results from the study demonstrate that Sutent provided benefit to patients by prolonging the median length of time they lived without the cancer spreading or worsening to 10.2 months compared to 5.4 months for patients who received placebo.

In patients treated with Sutent for neuroendocrine pancreatic tumors, the most commonly reported side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), stomach (abdominal) pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).

Sutent is also FDA-approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with GIST (gastrointestinal stromal tumor), a rare cancer of the stomach, bowel, or esophagus.

Sutent is marketed by New York City-based Pfizer.

Pazopanib (Votrient) Approved By The National Institute for Health and Clinical Excellence (NICE) For Treatment Of Advanced Renal Cell Carcinoma

The National Institute for Health and Clinical Excellence (NICE) is recommending Pazopanib (Votrient) as a first-line treatment option for people with advanced renal cell carcinoma (RCC) who have not previously received cytokine therapy and who are of Eastern Cooperative Oncology Group (ECOG) performance status 0-1, on the basis that GSK provided that an agreed patient access scheme agreed. The patient access scheme will offer straight discount of 12.5% (which will bring the price in par with Sunitinib) and makes provision for a possible partial rebate to the NHS in the future. The rebate  is conditional upon the outcome of a head-to-head trial with current standard of care treatment sunitinib (Sutent).
The study, COMPARZ, which started in 2008 will end in May 2011 and the results will be out in Mid 2012.
Usually NICE recommendations are accepted by UK National Health Service and this time NICE has recommended that NHS takes the deal.

Votrient is a type of medicine called a tyrosine kinase inhibitor (TKI) and it has been shown to effectively slow down the progression of advanced RCC whilst maintaining QoL compared with placebo; a significant consideration for patients at an advanced stage of disease.2,3 Votrient has an acceptable and manageable toxicity profile. The most frequent adverse events related to Votrient treatment were diarrhoea, hair colour change, hypertension, nausea, anorexia and increased liver enzymes.

Advanced RCC is an aggressive form of kidney cancer with a poor prognosis, due in part to its resistance to chemotherapy, radiotherapy and hormone therapy. Over 8,000 people in the UK are diagnosed with kidney cancer each year and around one third show signs of advanced RCC at the time of diagnosis.7-9 The introduction of targeted cancer therapies has transformed the management of advanced RCC. However, despite improvements in efficacy, side effects observed with available treatments to date can affect patients’ quality of life and their ability to carry out normal daily activities.12-17 This was acknowledged by the NICE Appraisal Committee in their evaluation of evidence from the patient experts and clinicians. With only one targeted treatment option (sunitinib) recommended by NICE as a first-line treatment until now,18 the NICE recommendation of Votrient will offer patients and clinicians a choice of effective treatment options with different side-effect profiles.

NICE statement