Articles tagged with: Myelodysplastic Syndromes
News »
Natco Pharma Applies To Sell Generic Lenalidomide In The U.S. – The Indian drug company Natco Pharma filed a request with the Food and Drug Administration to market generic lenalidomide before Celgene’s patents on Revlimid (lenalidomide) expire in 2026. Revlimid is approved in the U.S. for the treatment of myelodysplastic syndromes (MDS) as well as multiple myeloma. Investment analysts have speculated that the patent that extends Revlimid’s exclusivity from 2019 to 2026 is being challenged. Despite this application, the sale of generic lenalidomide is not likely for at least several years. Celgene plans to sue Natco for patent infringement, which would automatically result in a 30-month delay of Natco’s application to sell generic lenalidomide in order to settle the lawsuit. For more information, see the Dow Jones article.
New Myelodysplastic Syndromes Center Opens In New York City – NewYork-Presbyterian Hospital and Columbia University Medical Center have created a new myelodysplastic syndromes (MDS) center that will focus on research and treatment. Dr. Azra Raza, an MDS specialist from Columbia University, will head the new center. Research at the center currently includes the investigation of treatments with tolerable side effects for newly diagnosed MDS patients, as well as the use of genetic testing to determine which patients are most likely to respond to treatment. The center’s goals include controlling symptoms, improving quality of life, and improving survival. For more information, see the NewYork-Presbyterian website.
Headline, News »
Treatment with treosulfan and fludarabine was effective and caused few negative side effects in myelodysplastic syndromes patients receiving donor stem cell transplants, according to a recent clinical trial conducted by researchers in Washington and Oregon.
By the end of the trial, all surviving patients successfully achieved complete engraftment of the donor stem cells, meaning that the donor stem cells began producing healthy blood cells and none of the patient’s stem cells remained. Overall, the treatment was particularly effective in patients categorized as low- or standard-risk based on their genetics.
Only…
Headline, News »
This article is part of a series about stem cell transplantation in MDS, which will be published over the next couple of weeks. The series will explain the different types of stem cell transplants, describe the procedure for both patient and donor, address benefits and risks, and report on experiences of MDS patients who underwent the procedure.
In this final part of the series, MDS patients who underwent a donor stem cell transplantation share their experiences with the procedure and how it impacted their life after the transplant.
This article…
Headline, News »
A recent study of myelodysplastic syndromes patients who received a donor stem cell transplant showed that the percentage of donor versus patient stem cells in the bone marrow or blood may be able to predict relapse.
Stem cell transplants for myelodysplastic syndromes (MDS) patients are usually performed by giving the patient stem cells from a healthy donor. This is the only known cure for MDS.
Ideally, the patient’s blood-forming stem cells are destroyed and replaced by the donor’s healthy stem cells. The donor’s cells then grow in the patient and…
News »
Revlimid Receives Approval In Japan For Treatment Of Del-5q Myelodysplastic Syndromes – On Friday, Celgene announced that Japan’s Ministry of Health, Labour and Welfare, the agency that is responsible for the regulation of pharmaceuticals and medical devices in Japan, approved Revlimid (lenalidomide) for the treatment of myelodysplastic syndromes (MDS) associated with a deletion 5q chromosomal abnormality. The approval was based on the efficacy and safety demonstrated during several international clinical trials. In the U.S., the approved use of Revlimid also requires that del-5q MDS patients be dependent on red blood cell transfusions. For more information, please see the Celgene press release.
Conference For MDS Patients And Their Families – The MDS Foundation is sponsoring a one-day conference for patients with MDS and their families on September 9 at the Hilton University of Florida Conference Center in Gainsville. Dr. Christopher Cogle, an MDS specialist from Shands Hospital at the University of Florida, will speak about the latest on the diagnosis and treatment of MDS. The event will begin at 9 a.m. and conclude at 2 p.m. It will include breakfast and lunch and is free to attend. Registration is required. For more information or to register, please see the MDS Foundation website.
For a more detailed listing of MDS related events, please check the MDS Beacon Events Calendar.
Headline, News »
This article is part of a series about stem cell transplantation in MDS, which will be published over the next couple of weeks. The series will explain the different types of stem cell transplants, describe the procedure for both patient and donor, address benefits and risks, and talk about prognosis and life after the transplant.
Although stem cell transplants can cure MDS, they are associated with certain risks and complications.
This article will summarize the benefits and risks associated with the procedure.
Benefits
A stem cell transplant replaces an MDS…
Headline, News »
South Korean researchers have shown that myelodysplastic syndromes patients treated with Dacogen experienced fewer episodes of fever when given preventative antibiotic treatment.
“Preventative antibiotic treatment will reduce the infection risk of MDS patients receiving hypomethylating agents, especially during earlier treatment cycles and in the presence of severely low blood cell counts”, explained Dr. Je-Hwan Lee of the University of Ulsan College of Medicine and lead author of the study in an email to The MDS Beacon.
Dacogen (decitabine) is approved by the United States Food and Drug Administration for the…
Headline, News »
This article is part of a series about stem cell transplantation in MDS, which will be published over the next couple of weeks. The series will explain the different types of stem cell transplants, describe the procedure for both patient and donor, address benefits and risks, and talk about prognosis and life after a transplant.
Although stem cell transplants can cure myelodysplastic syndromes (MDS), not all patients are good candidates for the procedure. In general, the procedure is considered as a treatment option for younger patients with high-risk MDS who…
Headline, News »
Results of a recent study suggest that serum albumin, a protein in blood, may be a good factor to determine the prognoses of acute myeloid leukemia and myelodysplastic syndromes patients who have received an allogeneic stem cell transplant.
Stem cell transplantation is the only known cure for myelodysplastic syndromes (MDS). When patients undergo an allogeneic stem cell transplant, they receive healthy stem cells from a donor (For more information about stem cell transplantation, please see the related Beacon article).
However, not all patients are suitable for transplants, and more…
News »
Phase 1 Clinical Trial Of Potential MDS Treatment, Liposomal Grb-2, Begins – A Phase 1 clinical trial of a new agent called liposomal Grb-2 will evaluate the safety and tolerability of the treatment in patients with myelodysplastic syndromes (MDS) or leukemia. The trial, which is being conducted at MD Anderson Cancer Center, is still enrolling patients. Liposomal Grb-2 blocks the body’s production of the protein Grb-2, which is linked to leukemia and solid tumors. This novel treatment is being developed by the biotechnology company Bio-Path Holdings. For more information, see the Bio-Path Holdings press release (pdf) or the clinical trials registry for the study.
Medicare Denies Coverage Of Stem Cell Transplants For MDS – The Centers for Medicare and Medicaid Services (CMS) ruled that Medicare recipients with MDS will not receive coverage for donor stem cell transplantation unless participating in a qualified clinical trial. CMS decided that previous studies have not shown that transplants improve outcomes of Medicare recipients with MDS. However, in the interest of further studying the efficacy of transplantation for MDS, Medicare will cover transplantation costs for patients participating in certain clinical trials investigating transplants in Medicare beneficiaries. These include studies that investigate whether transplantation improves outcome, factors that predict outcome, or what treatment facility characteristics improve outcome. For more information, see the CMS Decision Memo.