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Amgen’s Xgeva solves adverse effect problems
  • By Lee Han-soo
  • Published 2019.03.07 14:25
  • Updated 2019.03.07 18:01
  • comments 0

Amgen’s Xgeva (ingredient: denosumab) has resolved adverse effect issues for treating skeletal complications in cancer patients with bone metastases, the company said in a news conference Thursday.

Lee Sang-jin, Amgen Korea’s senior medical advisor, explains how Xgeva has improved efficacy in treating patients with severe kidney problems, in a news conference at Amgen Headquarters in Yeoksam, southern Seoul, Thursday.

As the number of cancer survivors has increased in the long term, the management of skeletal complications of metastatic cancer patients has become essential. Such treatment is vital as skeletal complications reduce the patient's survival rate and increase the economic burden of patients and their families.

That explains why guidelines of major international conferences such as National Comprehensive Cancer Network (NCCN) and American Society of Clinical Oncology are recommending hospitals to treat bone metastasis immediately after diagnosis. However, the conventional bisphosphonate-based therapies had problems as it caused adverse effects while having difficulty in using patients suffering from a bad kidney condition.

Amgen said its Xgeva has resolved such issues as it demonstrated a superiority and non-inferiority to zoledronic acid in a large-scale phase 3 clinical trial involving about 5,000 patients with bone metastases breast, prostate and other solid cancers.

Management of these skeletal-related events (SRE) is essential in progressive prostate and breast cancer, where the rate of bone metastases is about 65 to 75 percent, it added.

The primary endpoint of the study was the period from the first post-diagnosis to the onset of skeletal complications. As a result, the company confirmed that denosumab was 8.2 months longer than zoledronic acid with 27.6 months. Also, kidney-related adverse reaction occurrence risk caused by treatment was 10 percent in the Xgeva group and 17 percent in the zoledronic acid group

“Xgeva is meant to be safer than traditional drugs in terms of kidney weakness, which affect many cancer patients,” said Lee Sang-jin, Amgen Korea’s senior medical advisor.

In patients with multiple myeloma, there is about a 60 percent chance that patients may also suffer from renal disease, which further shortens the survival period. Existing bisphosphonates treatment had a limited therapeutic effect due to exacerbation of kidney damage or induction of renal toxicity. Accordingly, the NCCN recommends bisphosphonates or Xgeva to patients with multiple myeloma, but recommend Xgeva for patients with renal impairment.

The most common cause of discontinuation of Xgeva was hypocalcemia. Although not dangerous, the most frequent occurrence was within six months of treatment. The company recommended that patients take calcium and vitamin D to control the adverse effect.

“The incidence of adverse reactions related to nephrotoxicity is much lower in the Xgeva group," Lee said. ”The benefit of Xgeva is that it does not require dose adjustments in patients with renal impairment."

Treatment goals for metastatic cancer are to slow, stop and reduce cancer growth, and increase survival, and Xgeva can help patients reach such goals with reduced economic burdens and improved treatment efficiency, she added.


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