Articles tagged with: Onyx Pharmaceuticals
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Onyx Pharmaceuticals announced this morning that it has completed submission of its application to the U.S. Food and Drug Administration (FDA) for the approval of carfilzomib as a treatment for relapsed and refractory multiple myeloma.
Onyx began submitting the application in January after the FDA granted carfilzomib “Fast Track” status, which expedites the review process by allowing the submission of application materials on a rolling basis. The company has requested priority review of the carfilzomib application, which, if granted by the FDA, could allow the drug to be launched in…
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Opinion: A Multiple Myeloma Patient’s Viewpoint On Randomized Clinical Trials – In the latest article published in the opinion section of The Myeloma Beacon, Dr. Jim Omel, a physician and multiple myeloma patient, wrote about how the clinical trial process could be changed to encourage greater participation among myeloma and other cancer patients. To receive a copy of all opinion articles when they are published or if you are interested in contributing an opinion piece, send an email to .
FDA Puts Carfilzomib On Fast Track For Treatment Of Multiple Myeloma – On January 31, Onyx Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved fast-track designation for carfilzomib, a second-generation proteasome inhibitor that has shown promising anti-myeloma activity as a single agent and in combination with Revlimid (lenalidomide) and low-dose dexamethasone (Decadron). The fast-track designation accelerates the review and approval process of drugs developed to treat serious or life-threatening illnesses. Onyx can now submit carfilzomib’s New Drug Application to the FDA on a rolling basis. For more information, please see the Onyx Pharmaceuticals press release.
Investigational Drug Siltuximab Enhances Melphalan Efficacy In Multiple Myeloma Cells – Pre-clinical results showed that the monoclonal antibody siltuximab (CNTO 328), which is being developed by Centocor Ortho Biotech, enhanced the activity of melphalan (Alkeran). Siltuximab increased melphalan’s toxicity to myeloma cells and neutralized interleukin-6, a protein that promotes growth and drug resistance of myeloma cells. Several clinical trials studying siltuximab in myeloma patients are ongoing. For more information, please see the study in the British Journal of Haematology (abstract).
Investigational Drug BI 2536 Is Active Against Multiple Myeloma Cells – Results from a recently published study show that BI 2536, which is being developed by Boehringer Ingelheim, induces cell death in multiple myeloma cells. BI 2536 inhibits an enzyme called polo-like kinase 1, which regulates the cell cycle and has been associated with the development of many cancers. Additionally, BI 2536 increased the efficacy of Velcade (bortezomib) and dexamethasone in these cell lines. The study authors concluded that the results suggest BI 2536 should be studied in clinical trials for multiple myeloma. For more information, please see the study in the journal Experimental Hematology (abstract).
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Onyx Pharmaceuticals announced today that it is delaying for at least six months its application to market carfilzomib, a new treatment for multiple myeloma, in the United States.
Prior to today’s announcement, Onyx had expected to submit carfilzomib’s new drug application to the U.S. Food and Drug Administration (FDA) by the end of this year.
Now the company says its application will be submitted “as early as mid-year 2011.”
In its announcement today, Onyx explained that the delay in carfilzomib’s U.S. marketing timeline is due to an…
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Onyx Pharmaceuticals announced yesterday the results of an ongoing Phase 2b trial of single-agent carfilzomib for heavily pre-treated relapsed and refractory multiple myeloma patients. The overall response rate after 12 cycles of single-agent carfilzomib treatment in this trial was 24 percent, and the median duration of response was 7.4 months.
According to Dr. Michael Kauffman, Chief Medical Officer of Onyx Pharmaceuticals, the company’s newly released results demonstrate the potential for carfilzomib to significantly improve the outlook for relapsed and refractory multiple myeloma patients.
He cited a recent study…
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Onyx Pharmaceuticals Initiates Phase 3 Myeloma Trial Of Carfilzomib – Onyx Pharmaceuticals on Wednesday announced the start of enrollment for an international Phase 3 trial of carfilzomib in relapsed/refractory multiple myeloma patients. The trial will enroll 700 patients and will test carfilzomib in combination with Revlimid (lenalidomide) and low-dose dexamethasone (Decadron) versus Revlimid and low-dose dexamethasone without carfilzomib. Carfilzomib is a proteasome inhibitor that prevents the growth and spread of myeloma cells by interrupting their protein-related cellular processes. For more information, please see the Onyx Pharmaceuticals press release and the clinical trial description.
EntreMed’s ENMD-2076 Shows Anti-Myeloma Activity – EntreMed announced last week that its new cancer compound ENMD-2076 showed significant anti-myeloma activity in pre-clinical studies. EntreMed has already launched a Phase 1 study in multiple myeloma patients. ENMD-2076 prevents the growth and spread of myeloma cells by interfering with cell division. For more information, please see the EntreMed press release and the clinical trial description.
IMF Will Hold Myeloma Patient & Family Seminar – The International Myeloma Foundation (IMF) will be holding a seminar for myeloma patients and their families August 13 to 14 in Philadelphia, PA. Myeloma experts Dr. Brian Durie and Dr. Robert Kyle are among the speakers scheduled to present during Saturday’s general session. The cost for the seminar is $60 per person. For more information or to register, please visit the IMF website.
For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.
