Amgen receives complete response letter for denosumab indication

The FDA recently issued a complete response letter for Amgen Inc.’s supplemental Biologics License Application for the RANK ligand inhibitor denosumab (XGEVA) to treat men with castration-resistant prostate cancer at high risk of developing bone metastases.

The complete response letter states that FDA cannot approve the application in its present form. The FDA determined that the effect on bone metastases-free survival was of insufficient magnitude to outweigh the risks of denosumab in the intended population, and requested data from an adequate and well-controlled trial demonstrating a favorable risk-benefit profile for denosumab that is generalizable to the U.S. population.

"We are reviewing the complete response letter and will work with FDA to determine any next steps," said Sean E. Harper, MD, of Amgen. "The FDA’s action today does not impact the approved indication of denosumab in the prevention of skeletal-related events in men with bone metastases from prostate cancer, which was acknowledged by the FDA and the advisory committee members who discussed the application."

Denosumab was approved in 2010 for the prevention of skeletal-related events in patients with solid tumors, including prostate cancer, metastatic to bone. The same agent was approved for men at high risk for bone fracture following androgen deprivation therapy for non-metastatic prostate cancer and for postmenopausal women with osteoporosis at high risk for fracture.

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