FDA Grants Priority Review Designation to Denosumab

ImageAmgen (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer. Filed in mid-May with the FDA, the Biologics License Application (BLA) submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three pivotal Phase 3 head-to-head trials versus Zometa(R) (zoledronic acid).

Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Consistent with priority review guidelines, the FDA will target an Agency action within six months of the application submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of Thursday, November 18.

"Many cancer patients with skeletal metastases suffer debilitating complications, despite receiving the best available therapies," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "In clinical trials, denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile. We believe that this priority review designation underscores the potential for denosumab to provide a meaningful advance over the current standard of care for patients with metastatic bone disease."

Bone metastases, the spread of tumors to the skeleton, are a serious concern for many patients with advanced cancer. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor, often producing serious clinical consequences such as fractures, spinal cord compression, or the need to receive radiation or surgery to bone. These events are collectively called SREs. The RANK/RANKL pathway is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. Denosumab is the first therapy to target this important pathway.

Amgen has also submitted marketing applications in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with our licensing partner, Daiichi-Sankyo Limited and a submission is planned in the near future.

Bone Metastases: Prevalence and Impact
Bone metastases occur in more than 1.5 million patients with cancer worldwide and are most commonly associated with cancers of the prostate, lung, and breast, with incidence rates as high as 75 percent of patients with metastatic disease (1).

The economic burden of U.S. patients with bone metastases is significant and is estimated to be $12.6 billion annually (2). Patients with bone metastases who experience an SRE incur significantly higher medical costs compared with those who do not experience an SRE (3).

About Denosumab and Amgen's Research in Bone Biology
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). The denosumab development program is the largest ever initiated by Amgen. This broad and deep development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials, testing the drug for the reduction of SREs in patients with breast and prostate cancer, as well as other solid tumors and multiple myeloma, for the amelioration of treatment-induced bone loss in patients with non-metastatic breast or prostate cancers, and for its potential to delay bone metastases in prostate cancer.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

1. Coleman RE and Brown. Skeletal complications of malignancy.Cancer Suppl.1997: 80(8):1588
2. Schulman K and Kohles J. Cancer. 2007;109:2334-2342.
3. GVD/Barber ISPOR 2008 Poster; Schulman 2007; Delea et al. 2006.

Most Popular Now

Most popular vitamin and mineral supplements provi…

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital...

Tiny particles could help fight brain cancer

Glioblastoma multiforme, a type of brain tumor, is one of the most difficult-to-treat cancers. Only a handful of drugs are approved to treat glioblastoma, and the median ...

New approach to immunotherapy leads to complete re…

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was...

Amgen Foundation and Harvard team up to offer free…

The Amgen Foundation and Harvard University today announced plans to launch a free online science education platform uniquely designed to level the playing field for aspi...

The Pfizer Foundation announces $5 million in gran…

The Pfizer Foundation announced a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for...

What would help or hinder patient participation in…

As clinical trials gear up with the aim of attaining the first FDA-approved treatments for mitochondrial disease, a new study reports for the first time what patients and...

New drugs could also be deployed against lung and …

A new anti-cancer drug may be effective against a wider range of cancers than previously thought. Using a mouse model and samples taken from cancer patients, a team from ...

Update on Phase III clinical trials of lanabecesta…

AstraZeneca and Eli Lilly and Company (Lilly) are discontinuing the global Phase III clinical trials of lanabecestat, an oral beta secretase cleaving enzyme (BACE) inhibi...

Pfizer to expand venture investing with $600 milli…

Pfizer Inc. (NYSE:PFE) today announced it plans to invest $600 million in biotechnology and other emerging growth companies through Pfizer Ventures, the company’s venture...

Soy lecithin NSAID combo drug protects against can…

When scientists at The University of Texas Health Science Center at Houston (UTHealth) applied a chemical found in soybeans to a non-steroidal anti-inflammatory drug (NSA...

Novartis receives positive CHMP opinion for Aimovi…

Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Aimovig® (erenumab) for t...

FDA takes action against 53 websites marketing una…

The U.S. Food and Drug Administration today announced that it has warned nine online networks, operating a total of 53 websites, that they must stop illegally marketing p...