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Xgeva (Prolia) - Denosumab Drug

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    Posted: Dec 01 2010 at 7:32am

FDA Approves Xgeva

http://www.drugs.com/xgeva.html

The U.S. Food and Drug Administration (FDA) has approved Xgeva (denosumab), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6 month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.





Edited by 123Donna - Jun 07 2016 at 7:15pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 26 2010 at 10:49am
Xgeva Delays Bone Complications in Women with Metastatic Breast Cancer

In a study of women with bone metastases from breast cancer, Xgeva™ (denosumab) delayed bone complications for five months longer than Zometa® (zoledronic acid). These updated results from a Phase III clinical trial were presented at the 2010 San Antonio Breast Cancer Symposium.

Metastatic cancer refers to cancer that has spread to distant sites in the body. Several types of cancer—including breast cancer—have a tendency to spread to the bone. Bone metastases can lead to serious problems such as fracture and spinal cord compression and may require treatment with surgery or radiation therapy.

Bisphosphonate drugs such as Zometa are commonly used to reduce the risk of complications from bone metastases. Researchers continue, however, to explore new approaches to treatment.

Xgeva is a drug that targets a protein known as the RANK ligand. This protein regulates the activity of osteoclasts (cells that break down bone). Xgeva was recently approved for the prevention of bone complications such as fracture in patients with bone metastases from solid (not blood-related) cancers.

To directly compare Xgeva to Zometa among breast cancer patients with bone metastases, researchers conducted a Phase III clinical trial among more than 2,000 patients. Study participants were assigned to receive either Xgeva or Zometa. Zometa is given intravenously, and Xgeva is given as a subcutaneous (under-the-skin) injection.

The objective of the study was to determine whether the occurrence of bone complications (“skeletal related events”) differed between the two study groups. The bone complications that were evaluated were fracture, radiation to the bone, surgery to the bone, and spinal cord compression.

  • Patients treated with Xgeva remained free of bone complications for a median of five months longer than patients treated with Zometa.
  • Overall survival was similar in the two groups.
  • Osteonecrosis of the jaw—an uncommon but serious side effect—occurred in 2.5% of patients treated with Xgeva and 1.8% of patients treated with Zometa.

The results of this study suggest that Xgeva is more effective than Zometa at delaying or preventing skeletal complications in breast cancer patients with bone metastases.

Reference: Stopeck A, Martin M, Ritchie D et al. Effect of denosumab versus zoledronic acid treatment in patients with breast cancer and bone metastases: results from the extended blinded treatment phase. Presented at the 33rd annual San Antonio Breast Cancer Symposium, December 8-12, 2010. Abstract P6-14-01.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Dec 26 2010 at 1:49pm
Good news and a good way to get ready to start the year!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Dec 26 2010 at 4:20pm
Dear Donna,

thank you for posting..

all the best,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: May 17 2011 at 8:10am

D-CARE Trial Studies Denosumab for Early-Stage Cancers

A trial focusing on the treatment of early-stage, non-metastatic breast cancer with a high risk of recurrence

Trial Starts: May 2010; Trial Ends: October 2021

Written By Michael J. Formica, MS, MA, EdM, Editor and Project Coordinator
Reviewed By Adam Brufsky, MD, PhD

A clinical trial looking at denosumab (Xgeva) as adjuvant treatment for women with early-stage breast cancer who are at high risk of recurrence is being conducted worldwide. The study is recruiting participants affected by Stage II or Stage III breast cancer.

Denosumab was recently approved by the Food and Drug Administration to help prevent bone damage in people.

To read the entire article:

http://www.lbbc.org/Understanding-Breast-Cancer/Clinical-Trials-Research-Studies/Featured-Clinical-Trials/D-CARE-Clinical-Trial?tr=y&auid=8350538
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Aug 17 2012 at 10:31am
Breast Cancer Patients With Bone Metastases Benefit From Denosumab
Treatment with denosumab resulted in a greater reduction in skeletal-related events in patients with breast cancerthat spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a phase III study published in Clinical Cancer Research, a journal of the American Association for Cancer Research. 

"Our data indicate that denosumab should be the treatment of choice for the prevention of skeletal-related events and hypercalcemia in patients with breast cancer that has metastasized to the bone," said Miguel Martin, M.D., Ph.D., professor of medicine and head of the Medical Oncology Service at Hospital General Universitario Gregorio Marañón in Madrid, Spain. 

Bone metastases can have devastating consequences for breast cancer patients including hypercalcemia, bone fractures, spinal cord compression and more, according to Martin. The introduction of bisphosphonates, such as zoledronic acid, into the clinic has delayed the onset of these skeletal-related events. However, the use of these drugs is associated with acute reactions and kidney toxicity. Denosumab has a mechanism of action that is more specific than zoledronic acid, and it does not cause these adverse events. 

Martin and colleagues have previously reported the phase III study results indicating that denosumab is superior to zoledronic acid in preventing skeletal-related events in women with breast cancer and bone metastases. In the study, they randomly assigned 2,046 patients with breast cancer to receive subcutaneous denosumab and intravenous placebo, or intravenous zoledronic acid and subcutaneous placebo. In their current analysis, the researchers further analyzed the data from that study to get more information about bone-related complications and quality of life. 

The data indicated that only 31 percent of patients on denosumab experienced a skeletal-related event compared with 36 percent assigned to zoledronic acid. Among those who experienced a skeletal-related event, few patients assigned denosumab experienced a second event while enrolled in the study. 

Treatment with denosumab reduced the need for radiation therapy to the bone by 26 percent, and those patients also had an 18 percent lower risk for developing a skeletal-related event or hypercalcemia of malignancy. Quality of life also improved. In addition, patients assigned to denosumab had fewer acute phase reactions associated with a flu-like syndrome and fewer adverse events related to kidney dysfunction compared with those assigned to zoledronic acid. 

"This analysis provides additional evidence of the superiority of denosumab over zoledronic acid," Martin said. "The clinical implication of this analysis is clear: Denosumab offers an improved therapeutic index with respect to the prior standard." 

Martin and colleagues plan to continue to evaluate the use of denosumab to prevent bone-related issues in cancer patients. Due to the drug's ability control the bone microenvironment and to curb the growth of breast cancer cells, they are also testing denosumab as a preventive adjuvant therapy for early breast cancer patients. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jan 16 2013 at 9:12pm
Bumping for Lillie
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Post Options Post Options   Thanks (1) Thanks(1)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2015 at 8:13am
Prolia (Xgeva) Cuts Breast Ca Relapse Risk in Postmenopausal Women

A drug that reduces fracture risk in postmenopausal breast cancer patients taking aromatase inhibitors (AIs) appears also to cut their risk of relapse, a researcher said here.

In a prospective randomized placebo-controlled trial, adjuvant denosumab (Prolia), given twice a year, was associated with a 19% improvement in disease-free survival (DFS), according to Michael Gnant, MD, of the Medical University of Vienna.

To read more:
http://www.medpagetoday.com/MeetingCoverage/SABCS/55136?xid=nl_mpt_DHE_2015-12-11&eun=g456405d0r


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Post Options Post Options   Thanks (0) Thanks(0)   Quote SagePatientAdvocates Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2015 at 8:50am
Thanks, Donna...

warmly,

Steve
I am a BRCA1+ grandson, son and father of women affected by breast/oc-my daughter inherited mutation from me, and at 36, was dx 2004 TNBC I am a volunteer patient advocate with SAGE Patient Advocates
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jun 07 2016 at 7:14pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jun 21 2016 at 6:25pm

'Holy grail' of breast cancer prevention in high-risk women may be in sight

Australian researchers have discovered that an existing medication could have promise in preventing breast cancer in women carrying a faulty BRCA1 gene.

People who carry a faulty BRCA1 gene are at high risk of developing aggressive breast cancer. Currently many women with a gene mutation choose surgical removal of their breast tissue and ovaries to reduce their chance of developing breast andovarian cancer.

By pinpointing the cells that give rise to breast cancers in women who have inherited a faulty version of the BRCA1 gene, Walter and Eliza Hall Institute researchers have identified that the drug denosumab may have potential to prevent breast cancer from developing. If confirmed in clinical studies, this would provide a non-surgical option to prevent breast cancer in women with elevated genetic risk.

Using samples of breast tissue donated by women carrying a faulty BRCA1 gene, Ms Emma Nolan, Professor Jane Visvader and Professor Geoff Lindeman were able to pinpoint the cells that give rise to breast cancer. The research, which also involved researchers at the Australian familial cancer consortium kConFab and US biotechnology company Amgen was published in Nature Medicine.

Cancer precursor cells in BRCA1-mutant breast tissue had many similarities to aggressive forms of breast cancer, said Ms Nolan, who is a PhD student at the institute enrolled through The University of Melbourne's Department of Medical Biology. "These cells proliferated rapidly, and were susceptible to damage to their DNA - both factors that help them transition towards cancer," she said. "We were excited to discover that these pre-cancerous cells could be identified by a marker protein called RANK."

Professor Lindeman, who is also a medical oncologist at The Royal Melbourne Hospital, said the discovery of RANK as a marker of cancer precursors was an important breakthrough, because inhibitors of the RANK signalling pathway were already in clinical use. "An inhibitor called denosumab is already used in the clinic to treat osteoporosis and breast cancer that has spread to the bone," he said. "We therefore investigated what effect RANK inhibition had on the cancer precursor cells in BRCA1-mutant breast tissue."

The research team showed that RANK inhibition switched off cell growth in breast tissue from women with a faulty BRCA1 gene and curtailed breast cancer development in laboratory models.

"We think this strategy could delay or prevent breast cancer in women with an inherited BRCA1 gene mutation," Professor Lindeman said. "A clinical trial has already begun to investigate this further."

"This is potentially a very important discovery for women who carry a faulty BRCA1 gene, who have few other options. Current cancer prevention strategies for these women include surgical removal of the breasts and/or ovaries, which can have serious impacts on people's lives. To progress this work, denosumab would need to be formally tested in clinical trials in this setting as it is not approved for breast cancer prevention," Professor Lindeman said.

Professor Visvader said the discovery had its basis in more than a decade of investigations of breast stem cell function. "By thoroughly dissecting how normal breast tissue develops, we have been able to pinpoint the precise cells that are the culprits in cancer formation," she said. "It is very exciting to think that we may be on the path to the 'holy grail' of cancer research, devising a way to prevent this type of breast cancer in women at high genetic risk."

http://www.medicalnewstoday.com/releases/311126.php

http://www.medicalnewstoday.com/articles/311096.php


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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Sep 26 2016 at 7:08pm
Osteoporosis Treatment May Reduce Breast Cancer Recurrence and Metastasis, Study Finds

Inhibition of the RANK pathway significantly reduces recurrence and metastasis in breast cancer mouse models, according to the results of a recent study published in Cancer Research.

The study, “RANK signaling blockade reduces breast cancer recurrence by inducing tumor cell differentiation,” shows that RANK inhibition reduces cancer stem cells (CSC) in invasive tumors, impairing the start of metastasis, and enhances sensitivity to chemotherapy.

“Mortality in breast cancer is mainly due to survivor CSC after treatments, which are responsible for tumor recurrence and metastasis,” Dr. Eva Gonzalez-Suarez, the study’s lead author, said in a press release. “Previous studies of this and other research groups have shown that inhibition of RANK pathway may prevent breast cancer, but no one had proven the potential of RANK pathway inhibitors in the treatment of disease.”

In normal conditions, the RANK signaling pathway works to promote the development of the mammary gland in response to signals provided by sex hormones, such as progesterone. This usually happens in all women during their menstrual cycles and during pregnancy, but if the RANK signaling becomes disregulated, the mammary cells start reproducing rapidly when they are not supposed to, eventually leading to breast cancer.

Expression of RANK in human cancers is linked with reduced overall survival, but the therapeutic potential of RANK inhibitors once tumors have developed remained to be addressed.

In this study, Gonzalez-Suarez and her team used a breast cancer mouse model with high RANK expression and explored whether RANKL inhibitors could be used to prevent cancer progression.

The researchers found that “this inhibition does not reduce tumor growth, but promotes differentiation, reducing the population of CSC and impairing metastasis, which improves the prognosis,” suggesting that inhibition of the RANK/RANKL pathway could be potentially used as a new therapy in breast cancer.

Importantly, RANKL inhibitors, such as Prolia (denosumab), are already approved in the clinic and are indicated for the treatment of bone related diseases, osteoporosis, and bone metastasis, and thus may quickly become available for patients with advanced breast cancer.

“As these preclinical experiments suggest, and given that the RANKL / RANK pathway plays an important role in the development of primary breast cancer, inhibitors could serve as a potential target for the prevention and nonsurgical treatment of breast cancer,” Gonzalez-Suarez said.

http://breastcancer-news.com/2016/09/21/osteoporosis-treatment-may-reduce-breast-cancer-recurrence


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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 16 2016 at 12:17pm
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