Amgen Wins FDA Approval For New XGEVA Indication

Published: Dec 09, 2014

Amgen Wins FDA Approval For New XGEVA Indication
December 9, 2014
By Mark Terry, Breaking News Staff

Thousand Oaks, Calif.-based Amgen announced yesterday that the U.S. Food and Drug Administration has approved the company’s XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

The compound was given Orphan Drug Designation by the FDA, which is a category describing drugs for the treatment of rare diseases. Rare diseases are defined as afflicting fewer than 200,000 individuals in the U.S.

“Our continued study of XGEVA reinforces Amgen’s ongoing commitment to address the unmet needs of cancer patients,” said Sean Harper, Amgen’s executive vice president of research and development, in a statement. “This latest FDA approval for XGEVA provides an important new therapeutic option for patients with a rare condition that cannot be resolved with bisphosphonate therapy.”

Under hypercalcemia of malignancy, patients bones break down very quickly. It is related to advanced cancer and can lead to bone fractures, kidney failure, mental impairment, coma and death.

XGEVA is marketed for the prevention of skeletal damage caused by solid tumors, and also for cases of a very rare condition, giant cell tumor of bone, which is inoperable. The FDA approval for XGEVA for HCM is a new approval. The drug is also marketed for osteoporosis under the name Prolia.

Recent sales of XGEVA and Prolia increased by 31 percent to $573 million the third quarter. In morning trading Amgen shares gained $2.21 to $171.45. The company’s stocks have climbed 48 percent this year.

This most recent approval was based on positive results from an open-label, single-arm clinical study. Participants in the study had advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The study’s primary endpoint was the proportion of participants with a response; the response was defined as albumin-corrected serum calcium (CSC) less than or equal to 11.5 mg/dl within 10 days after the first dose.

The study met those endpoints with a response rate of 63.6 percent at day 10 in the 33 patients enrolled in the study. The drug is administered as a subcutaneous injection every four weeks, with extra doses on days eight and 15 during the first month. The most common side effects observed were nausea, decreased appetite, headache, vomiting, anemia, constipation and diarrhea.

XGEVA’s action involves binding to RANK Ligand (RANKL), a protein necessary to the function and survival of osteoclasts, the cells that handle bone resorption. As a result XGEVA modulates calcium release from the bone.

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