Press Releases»

News»

Good morning, myeloma world.

We hope you had a pleasant weekend and that your new week is off to a good start.

The big news today is that Darzalex (daratumumab) has been approved in Europe as a new treatment for multiple myeloma. We will be pub­lish­ing a separate news article on the approval, which was announced a few hours ago. In the mean­time, you can find information about the approval in this press release from Genmab, the company that initially developed Darzalex.

The other news we have for you …

News»

Good morning, myeloma world.

Since the last edition of Myeloma Morning, abstracts for two im­por­tant upcoming medical meetings have been made public: the American Society of Clinical Oncology (ASCO) annual meeting, which will take place June 3 through June 7 in Chicago, and the European Hematology Association (EHA) annual congress, which is scheduled for June 9 through June 12 in Copenhagen, Denmark.

The publication of the abstracts and the meetings themselves mean that there is going to be a lot of multiple myeloma-related news in the coming weeks. We will do our …

NewsFlash »

Anti-Cancer Virus May Enhance Efficacy Of Velcade Against Myeloma – Results from a recent preclinical study in myeloma cells show that Velcade (bor­tezo­mib) inhibits replication and spread of the anti-cancer vesicular sto­ma­titis virus (VSV).  However, when both were administered to mice with multiple myeloma, the combination more effectively killed myeloma cells than either the virus or Velcade alone. The researchers conclude that these latter findings sup­port clinical study of VSV in combination with Velcade for the treat­ment of mye­lo­ma.  VSV, which belongs to the same family of viruses as the rabies virus, can infect insects, animals, and humans, causing flu-like illness in humans.  VSV also attacks and kills cancer cells.  It is currently being studied in a clinical trial for the treat­ment of liver cancer and in preclinical studies for melanoma, lung cancer, colon cancer, and certain brain tumors.  The VSV used in the recent preclinical study was genetically modified to specifically target myeloma cells and to reduce side effects.  In addition, a component was added to the virus so that spread of the virus could be monitored.  For more information, see the study in Experimental Hema­tol­o­gy (abstract).

Preclinical Study Shows BAY80-6946 May Be Effective Against Myeloma – Results from a recent pre­clinical study show that the compound BAY80-6946 kills multiple myeloma cells.  Specifically, BAY80-6946 reduced growth of myeloma cells grown in the laboratory and cells isolated from myeloma patients by up to 50 percent.  It also killed 70 percent to 87 percent of myeloma cells in mice with multiple myeloma, without observed side effects.  BAY80-6946 is an investigational myeloma treat­ment being developed by the Ger­man pharmaceutical company Bayer.  It belong to a class of drugs that block an enzyme in cancer cells known as phos­pho­inositide 3-kinase (PI3K). By in­hibit­ing PI3K, BAY80-6946 disrupts the cell division cycle and causes cancer cell death.  BAY80-6946 is in Phase 1 trials as a potential treat­ment for a variety of dif­fer­ent solid tumors, and it is also in a Phase 2 trial for non-Hodgkin's lymphomas.  Perifosine is another in­ves­ti­gational drug that belongs to the same class of drugs as BAY80-6946.  Perifosine was also being developed for the treat­ment of multiple myeloma; however, it lacked significant efficacy in a Phase 3 mye­lo­ma clinical trial and is no longer being studied.  For more information about the BAY80-6946 study, see the related article in Blood Cancer Journal.

More Doxil Shortages Expected – Janssen Products, the manufacturer of Doxil (doxorubicin liposomal), announced in a letter to health care providers at the end of September that the supply of Doxil will be inter­rupted due to difficulties at their external manufacturer. Janssen expects the shortages to take effect the middle or end of October. Doxil is currently approved in combination with Velcade for previously treated multi­ple myeloma patients. The company asked physicians not to start any new patients on Doxil until further notice. In the meantime, Janssen is working closely with the U.S. Food and Drug Administration (FDA) to establish other ways to ensure a reliable drug supply.  However, a generic version of Doxil is available since receiving FDA approval in February (see related Beacon news).  The current Doxil shortage is the second in two years. Doxil was in limited supply from August 2011 to October 2012 due to manufacturing problems (see related Beacon news).  For more information about the current shortage, see the Janssen Products announcement (pdf) and a related FDA announcement. Updates on the situation will be available on the Doxil website.

News»

Researchers from the Moffitt Cancer Center recently published results from a Phase 2 clinical trial that investigated the combination of Revlimid plus Doxil and low-dose dexa­metha­sone as initial therapy for patients with newly diag­nosed multiple myeloma.

Although the results show an overall re­sponse rate of 77 per­cent, a medi­an progression-free survival time of 28 months, and a one-year overall survival rate of 98 per­cent for the Revlimid (lenalidomide), Doxil (doxo­ru­bi­cin liposomal), and dexa­metha­sone (Decadron) combination, the re­search­ers indicate that this combination is not an improvement on …

News»

Results from a small Phase 2 study conducted in Italy demon­strate that se­quen­tial treatment with novel agents and au­tol­o­gous stem cell trans­plan­ta­tion with intermediate-dose melphalan is a safe and ef­fec­tive treat­ment for older, newly diagnosed myeloma patients.

“This is the first study with a sequential approach of Velcade in­duc­tion, autol­o­gous stem cell trans­plan­ta­tion, and Revlimid main­te­nance,” said the study’s lead investigator, Dr. Antonio Palumbo of the University of Torino in Italy.

The regimen was safest in patients under the age 70; patients aged 70 years and older ex­peri­enced more treatment-related side effects …

News»

[ by Virginia Li | Feb 20, 2013 3:30 pm | Comments Off ]

Results of a small Phase 2 study may lead to improved outcomes for newly diagnosed patients who are unable to achieve a deep response with a Revlimid- or thalidomide-based initial therapy.

The study indicates that follow-on treatment with a Velcade-based regimen can noticeably deepen responses in these patients.

“We were certainly pleased to see that we were able to confirm our hypothesis that offering Velcade-containing, non-cross-resistant combinations to patients whose response had stalled after [Revlimid- or thalidomide-] based therapy can improve the depth of response,” said the study’s lead investigator, Dr. Ruben …