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Physicians in the United States are able to prescribe Kyprolis for their patients now that the drug has been approved for the treat­ment of multiple myeloma.

The drug's widespread availability, however, raises the important question: For what types of myeloma patients are physicians likely to prescribe Kyprolis?

Last month, the U.S. Food and Drug Administration (FDA) approved Kyprolis (car­filz­o­mib) for the treat­ment of multiple myeloma patients meeting specific criteria. The patients must have received at least two prior ther­a­pies, including Velcade (bor­tez­o­mib) and an immuno­modu­la­tory agent, meaning either Revlimid (lena­lido­mide), …

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[ by Navneet Ramesh | Aug 6, 2012 10:40 am | Comments Off ]

Final results from a Phase 2 study show that Kyprolis can be an effective treat­ment for re­lapsed and refractory multiple myeloma patients, with nearly a quarter of these patients responding to treat­ment.

Dr. David Siegel, from the John Theurer Cancer Center and lead investigator of the study, said the results dem­onstrate that Kyprolis (car­filz­o­mib) has “excellent activity with low toxicity.”

Based on the results of this study, the U.S. Food and Drug Administration recently approved Kyprolis for use in re­lapsed and refractory multiple myeloma patients (see related Beacon news).

“Patients …

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Kyprolis Is Now Available In The United States – The newly approved myeloma treat­ment Kyprolis (car­filz­o­mib) is available on the U.S. market starting today. The U.S. Food and Drug Administration (FDA) approved Kyprolis on July 20 for the treat­ment of multiple myeloma patients who have received at least two prior ther­a­pies (see related Beacon news). Physicians can now prescribe Kyprolis to myeloma patients throughout the U.S. To learn more about the recent FDA approval of Kyprolis and the drug's launch, please see The Beacon’s detailed questions and answers article published last week.

Exelixis Starts Clinical Trial Of Cabozantinib In Patients With Relapsed Or Refractory Myeloma – Exelixis, a bio­pharma­ceu­tical com­pany based in South San Francisco, announced last week the start of a Phase 1 trial of cabozantinib (XL184) in multiple myeloma. Cabozantinib is a com­­pound that inhibits the activity of two key enzymes, at least one of which is known to promote the growth of myeloma cells. The study will in­ves­ti­gate the safety, tolerability, and preliminary activity of cabozantinib in patients with re­lapsed or refractory multiple myeloma with bone disease. Cabozantinib is also being in­ves­ti­gated as treat­ment for several other types of cancers, including non-small cell lung cancer, prostate cancer, and thyroid cancer. For more in­­for­ma­tion, please see the Exelixis press release and the clinical trial description.

KW-2478 Plus Velcade Shows Potent Anti-Myeloma Activity In Preclinical Study - Results from a recent preclinical study indicate that a com­bi­na­tion of the investigational drug KW-2478 with Velcade (bor­tez­o­mib) has potent anti-myeloma activity. KW-2478 belongs to a class of anti-myeloma drugs called Hsp90 inhibitors and is being developed by Japanese drug manu­­fac­­turer Kyowa Hakko Kirin. Other Hsp90 inhibitors which have been in­ves­ti­gated as potential myeloma treat­ments include ganetespib and tanespimycin.  In the recent study involving KW-2478, researchers found that the drug increased the ability of Velcade to kill myeloma cells. In mice, the com­bi­na­tion also reduced bone lesions and mono­clonal protein levels (M-spike) more effectively than either drug alone. According to the study investigators, these results strongly suggest that the com­bi­na­tion could be an effective treat­ment for multiple myeloma patients. For more in­­for­ma­tion, please refer to the study in the Blood Cancer Journal (abstract).

Purifying Plasma Cells From Bone Marrow Samples May Facilitate Detection of Chromosomal Abnormalities – Findings from a recent Dutch study suggest that chromosomal ab­nor­mal­i­ties in cancerous plasma cells may be easier to detect in purified plasma cell samples from bone marrow samples, as compared to unpurified (whole) marrow samples from myeloma patients. Previous studies have shown that certain chromosomal ab­nor­mal­i­ties in cancerous plasma cells can predict poorer myeloma prognosis. In this study, researchers could identify plasma cell chromosomal ab­nor­mal­i­ties in 96 per­cent of purified samples from bone marrow samples, as compared to 61 per­cent in unpurified samples. They argued that the low frequency of plasma cells in unpurified bone marrow samples hindered the detection of ab­nor­mal­i­ties. The researchers found that genetic material isolated from purified plasma cells could also be analyzed by molecular techniques to yield addi­tional in­­for­ma­tion about each patient's myeloma. For more in­­for­ma­tion, please see the study in Genes, Chromosomes and Cancer (abstract).

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Biotest AG Starts Clinical Trial Of BT-062 Combination Therapy – The German pharma­ceu­tical com­pany Biotest AG has begun a Phase 1/2 clinical trial of BT-062 in com­bi­na­tion with Revlimid (lena­lido­mide) and dexamethasone (Decadron) in patients with re­lapsed and/or refractory multiple myeloma. BT-062 consists of a chemotherapeutic drug com­bined with an anti­body that helps deliver the drug to myeloma and other cancer cells. BT-062 alone has dem­onstrated anti-myeloma activity and good tolerability in re­lapsed and refractory myeloma patients. Furthermore, preclinical studies have shown BT-062 to be more effective when com­bined with Revlimid. For more in­­for­ma­tion, please see the Biotest AG press release and the clinical trial description.

Kyprolis And Oprozomib May Decrease Bone Damage In Multiple Myeloma – The results of a preclinical study suggest that Kyprolis (carfilzomib) and oprozomib may prevent bone loss in multiple myeloma. Kyprolis and oprozomib are both being developed by Onyx Pharmaceuticals, and both belong to the same class of drugs as Velcade (bor­tez­o­mib), known as proteasome inhibitors. Kyprolis was approved last week by the U.S. Food and Drug Administration for the treat­ment of people with multiple myeloma who have received at least two prior ther­a­pies (see related Beacon news). Oprozomib, which will be admin­istered orally, is still in the early clinical devel­op­ment phase. In this study, researchers found that car­filz­o­mib and oprozomib enhanced bone formation and decreased bone destruction in healthy mice. Additionally, in mice with multiple myeloma, treat­ment with car­filz­o­mib or oprozomib resulted in a smaller tumor burden and prevented bone destruction. For more in­­for­ma­tion, please see the study in Leukemia (abstract).

NDC May Overcome Multidrug Resistance And Prevent Doxorubicin-Induced Heart Disease In Myeloma Patients – The results of a recent preclinical study show that a doxorubicin-curcumin com­­pound called NanoDoxCurc (NDC) may overcome resistance to doxorubicin (Adriamycin) while preventing treat­ment-related heart disease. Doxorubicin is a common anticancer agent that becomes less effective in cancer cells demonstrating multidrug resistance. In higher doses, doxorubicin can overcome multidrug resistance, but is also asso­ci­ated with heart disease. In this study, NDC-treated mice with multiple myeloma dem­onstrated lower tumor burdens than mice treated with doxorubicin alone. Furthermore, mice treated with NDC did not experience heart com­pli­ca­tions. The study investigators believe these findings indicate that NDC may be a safe and long-lasting cancer ther­apy. For more in­­for­ma­tion, please see the study in Oncotarget.

BCMA Levels May Be A Disease Marker In Multiple Myeloma – In a recent study, researchers found that B-cell maturation antigen (BCMA) levels in the blood are elevated in multiple myeloma patients and are asso­ci­ated with disease status and over­all survival. BCMAs can be found on the surface of both normal and cancerous B-cells, a type of white blood cell. In the current study, BCMA levels in the blood were higher in multiple myeloma patients compared to those in healthy adults. Furthermore, patients with progressive disease dem­onstrated higher BCMA levels than those who were responsive to treat­ment. After a median follow-up time of 11 months, patients with BCMA levels above the median had shorter over­all survival times than patients below the median. For more in­­for­ma­tion, please see the study in the British Journal of Haematology (abstract).

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Last week, the U.S. Food and Drug Administration (FDA) approved Kyprolis (car­filz­o­mib) for the treat­ment of multiple myeloma patients who have received at least two prior ther­a­pies (see related Beacon news).

In this article, The Beacon addresses important questions multiple myeloma patients have been asking about the FDA decision.

What exactly did the FDA approve?

The FDA approved Kyprolis for the treat­ment of multiple myeloma patients meeting specific criteria.  The patients must have received at least two prior ther­a­pies.  These two ther­a­pies must have included Velcade (bor­tez­o­mib) and an …

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The United States Food and Drug Administration (FDA) has approved carfilzomib, which will be marketed under the brand name Kyprolis, for the treat­ment of people with multiple myeloma who have received at least two prior ther­a­pies.

Specifically, Kyprolis has been approved for myeloma patients who have already been treated with at least Velcade (bor­tez­o­mib) and either Revlimid (lena­lido­mide) or thalido­mide (Thalomid) and who have also progressed on or within 60 days of completing their last ther­apy.

“I am very pleased,” said Dr. Vincent Rajkumar from the …

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Phase 3 Trial To Compare Carfilzomib and Velcade For Relapsed Multiple Myeloma – On Monday, Onyx Pharmaceuticals announced the start of a Phase 3 trial comparing the safety and efficacy of its investigational drug carfilzomib (Kyprolis) to that of Velcade (bor­tez­o­mib). In particular, the trial will in­ves­ti­gate the efficacy and safety of car­filz­o­mib in com­bi­na­tion with dexamethasone (Decadron) versus Velcade plus dexa­meth­a­sone in patients who have received one to three prior lines of ther­apy. Carfilzomib is in the same class of drugs as Velcade, known as proteasome inhibitors. It is cur­rently under review by the U.S. Food and Drug Administration for potential approval as a new treat­ment for myeloma (see related Beacon news). For more in­­for­ma­tion, please see the Onyx Pharmaceuticals press release and the clinical trial description.

Phase 3 Trial Of MLN9708 Begins In Patients With Relapsed Or Refractory Myeloma – Millennium Pharmaceuticals, the com­pany that developed Velcade and markets the drug in the United States, announced last week the initiation of an inter­na­tional Phase 3 clinical trial of its investigational com­­pound MLN9708 (ixazomib) in patients with re­lapsed or refractory multiple myeloma. The study will in­ves­ti­gate the efficacy and safety of MLN9708 in com­bi­na­tion with Revlimid (lena­lido­mide) and dexa­meth­a­sone. Like car­filz­o­mib and Velcade, MLN9708 is a proteasome inhibitor; however, it is admin­istered orally. In recent Phase 1/2 clinical trials, MLN9708 showed promising results as a single agent as well as in com­bi­na­tion with Revlimid and dexa­meth­a­sone in both newly diagnosed and re­lapsed/refractory myeloma patients (see related Beacon news). For more in­­for­ma­tion, please see the Millennium press release and the clinical trial description.

Researchers Identify Potential Reason For Drug Resistance In Some High-Risk Multiple Myeloma Patients – Researchers from the United States and Singapore have found that a small molecule of RNA called ACA11 may be the reason for drug resistance in multiple myeloma patients with the chromosomal ab­nor­mal­ity t(4;14). Specifically, the researchers found that ACA11 was present in all the cancer cells of patients with t(4;14). As the amount of ACA11 increased, levels of oxidative stress that damage cells went down, protecting cancer cells from damage. As a result, the cancer cells were more resistant to chemotherapy. Patients with t(4;14), which is a translocation of a region of chromosome 4 to chromosome 14, are considered high-risk patients (see related Beacon news). For more in­­for­ma­tion, please see the study in The Journal of Clinical Investigation and the Washington University in St. Louis press release.

Japanese Phase 1 Trial To Study Perifosine For Refractory Myeloma – The Canadian bio­tech com­pany Aeterna Zentaris announced last week that its partner in Japan, Yakult Honsha, has begun a Phase 1 clinical trial of perifosine (KRX-0401) in multiple myeloma patients who are resistant to Velcade treat­ment. The study will evaluate the safety of  perifosine in com­bi­na­tion with Velcade and dexa­meth­a­sone in 18 patients. Perifosine is an orally admin­istered drug that belongs to a new class of anti-cancer drugs called “Akt inhibitors.” In the United States, perifosine in com­bi­na­tion with Velcade and dexa­meth­a­sone is in Phase 3 trials for multiple myeloma (see related Beacon news). For more in­­for­ma­tion, please see the Aeterna Zentaris press release.