Beacon NewsFlashes – February 11, 2013
FDA Approves Generic Doxil – The FDA recently approved a generic version of Doxil (doxorubicin liposomal), a drug used to treat several different cancers, including multiple myeloma. Doxil was in limited supply from August 2011 to October 2012 due to manufacturing problems. However, the generic version will be readily available in 20 mg or 50 mg vials. Doxil kills cancers cells by damaging their DNA. When used as a treatment for multiple myeloma, the drug is typically combined with Velcade (bortezomib). For more information, please see the related FDA press release
Researchers Develop New Technique To Identify Kyprolis-Resistant Myeloma Cells – Researchers from George Washington University have developed a new technique that can identify multiple myeloma cells resistant to treatment with Kyprolis. The technique involves the use of an imaging dye known as CDy1, which the researchers found effective for identifying myeloma cells with high levels of the gene ABCB1. The cells with high levels of ABCB1 were found, in turn, to be resistant to treatment with Kyprolis (carfilzomib). Based on their findings, the researchers conclude that their new technique may help determine whether levels of the ABCB1 gene can predict how well a multiple myeloma patient will respond to treatment with Kyprolis. For more information, please refer to the study in the American Journal of Hematology (abstract) and the related press release from George Washington University.
MGUS Patients May Have Increased Risk Of Developing MDS – Results of a recent study indicate that, compared to the general population, patients with monoclonal gammopathy of undetermined significance (MGUS) have a 2.4 times higher risk of developing the blood disorder myelodysplastic syndromes (MDS). However, the study also found that MGUS patients do not have a significantly increased risk of developing acute myeloid leukemia or acute lymphoblastic leukemia. For more information, please see the study in the journal Leukemia (abstract).
BI-505 Shows Limited Activity In Multiple Myeloma – Preliminary results from a Phase 1 clinical trial indicate that investigational drug BI-505 shows limited activity in multiple myeloma. However, the study investigators note that the drug had a favorable safety profile. Data from the trial are available for 29 myeloma patients, all of whom had at least two previous treatment regimens before entering the trial. Increasing doses of BI-505 were tested during the study, but the best response seen was stable disease for at least two months, which was observed in 24 percent of the patients. None of the trial participants achieved a partial response or better. BI-505, which is being developed by the Swedish pharmaceutical company BioInvent, is an antibody that binds selectively to myeloma cells, triggering their death. BioInvent has described the trial results as "encouraging," and plans to test the 10 mg/kg dose of BI-505 in a future Phase 2 trial. For more information, please see the BioInvent press release.
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re: carfilzomib resistance ... This is a quote from the paper: "chemosensitization of MM cells to carfilzomib could be achieved in vitro by cotreatment with vismodegib, a hedgehog pathway antagonist which is currently in MM clinical trials"
Thank you, Dr. Goldberg, for your comment. You are correct that the article by the George Washington University researchers also reports that they found that Erivedge (vismodegib) appears to increase the sensitivity of myeloma cells to treatment with Kyprolis. We did not report this finding partly to keep our news item from becoming too long, and partly because the investigators themselves focused in the title of their article on their findings related to identifying Kyprolis-resistant myeloma cells.
As a bit of additional information for our readers, Erivedge was approved by the FDA last summer as a new treatment for basal cell skin cancer which either has spread to other parts of the body, relapsed after surgery, or cannot be treated with surgery or radiation. It is not approved by the FDA as a treatment for myeloma. However, there is an ongoing clinical trial in the Baltimore area which is investigating Erivedge as a treatment for myeloma patients who have had a stem cell transplant and have either relapsed or are in remission but have high-risk disease. Here is a link to further information on that trial:
http://clinicaltrials.gov/ct2/show/NCT01330173