Articles tagged with: Onyx Pharmaceuticals
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Onyx Pharmaceuticals, the South San Francisco, California-based company that developed and now markets Kyprolis (carfilzomib), announced yesterday evening that it is being acquired by Amgen.
Amgen (NASDAQ:AMGN), which is based outside of Los Angeles, is the world’s largest biotech company.
Within the multiple myeloma community, Amgen is known most for its anemia medications – Aranesp (darbepoetin alfa) and Epogen (epoetin alfa, also marketed as Procrit and Eprex) – as well as its drugs that increase the body’s production of white blood cells – Neupogen (filgrastim) and Neulasta …
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Myeloma-Related Presentations From The International Conference On Malignant Lymphoma – Three broad-ranging myeloma-related presentations were given at the recent International Conference On Malignant Lymphoma in Lugano, Switzerland, and full-text articles related to the presentations are available for free online. During the conference, Dr. Vincent Rajkumar from the Mayo Clinic spoke about initial therapy in myeloma, Dr. Leif Bergsagel from the Mayo Clinic discussed molecular classification and risk stratification in myeloma, and Dr. Philippe Moreau from the University Hospital in Nantes, France, discussed consolidation and maintenance therapy in multiple myeloma. The full-text articles from Dr. Rajkumar, Dr. Bergsagel, and Dr. Moreau are available from the journal Hematological Oncology.
Celgene And MorphoSys To Collaborate On Development Of MOR202 – The pharmaceutical companies Celgene and MorphoSys have announced that they will be collaborating on the development of the investigational drug MOR202 for the treatment of multiple myeloma and certain leukemias. MOR202 belongs to the same class of drugs as daratumumab and elotuzumab, called monoclonal antibodies. Like daratumumab, MOR202 binds to the CD38 molecule, which is found on the surface of multiple myeloma and other blood cancer cells. Once MOR202 is bound to the CD38 molecule on cancer cells, it signals for the immune system to kill the cells. The fact that MOR202 and daratumumab both target the CD38 molecule has sparked interest in MOR202's potential as a myeloma treatment, given the promising activity daratumumab has shown against myeloma in early-stage trials (see related Beacon news). MOR202 is currently being investigated in a Phase 1/2 trial for relapsed and refractory multiple myeloma. For more information, please see the related press release from Celgene and MorphoSys and the description of the MOR202 myeloma clinical trial.
Cancer Drug Erbitux Shows Limited Activity In Myeloma – Results of a recent, small Phase 2 clinical trial conducted in Germany show that the cancer drug Erbitux (cetuximab) has limited activity in relapsed and refractory multiple myeloma patients. Erbitux, which is already approved for treatment of colon cancer and head and neck cancer, also belongs to the class of drugs known as monoclonal antibodies. Among the 15 patients included in the study, 13 percent reached stable disease as best response to treatment with Erbitux alone. An additional 7 percent reached a partial response and 27 percent stable disease when dexamethasone (Decadron) was added to Erbitux treatment. Since Erbitux was safe according to the study investigators, they nevertheless recommend further development of Erbitux in combination with other agents in multiple myeloma. For more information, please see the study in the journal Leukemia & Lymphoma (subscription or purchase required).
Onyx Turns Down Amgen Acquisition Offer, Seeks Alternative Bids - Onyx Pharmaceuticals, the company that developed and markets the myeloma treatment Kyprolis (carfilzomib), reported over the weekend that it has received, and turned down, an acquisition offer from the biotech company Amgen. In response to Amgen's offer, Onyx said that it will seek and consider acquisition offers from other companies, although it also is leaving open the possibility that it will remain independent. Other companies which may be interested in acquiring Onyx, besides Amgen, include Pfizer, Bayer, Novartis, Genentech (Roche), and Celgene. In addition to Kyprolis, Onyx also is developing the potential new anti-myeloma therapy oprozomib, which, like Kyprolis, Velcade (bortezomib), and the investigational compound ixazomib (MLN9708), belongs to the class of drugs known as proteasome inhibitors. For additional information, please see the related press release from Onyx.
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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 (Kyprolis) 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 the …
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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 FDA request …
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Onyx Pharmaceuticals announced yesterday the results of an ongoing Phase 2b trial of single-agent carfilzomib (Kyprolis) 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 conducted by …
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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.