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Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced earlier today that the U.S. Food and Drug Administration (FDA) has granted "standard review designation" to the com­pany's New Drug Applica­tion for car­filz­o­mib.

This means that the FDA expects to make a decision by July 27, 2012, on Onyx's application to market carfilzomib (Kyprolis) in the United States.

The announcement is a disappointment for Onyx, which had hoped to receive a so-called "priority review" of the car­filz­o­mib application.

The target FDA review time for applications granted …

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Yesterday was the first day of the American Society of He­ma­tol­ogy (ASH) 2011 annual meeting, which is being held in San Diego.

Although the day featured no oral pre­sen­ta­tions of new myeloma-related re­search, it started with an in­ter­est­ing educational session focused on mul­ti­ple myeloma.

There also were a num­ber of poster pre­sen­ta­tions during the day summarizing im­por­tant new re­search findings.

The educational session in the morn­ing featured three pre­sen­ta­tions by lead­ing myeloma spe­cialists.

Induction Therapy And Maintenance Treatment

The first pre­sen­ta­tion was by Dr. Donna Reece of the Princess Margaret Hospital in …

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Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced this morning that the U.S. Food and Drug Administration (FDA) has accepted the com­pany's New Drug Applica­tion for car­filz­o­mib.

The announcement means that the FDA will now begin its full review of carfilzomib (Kyprolis).

The length of time required for that review depends on whether the FDA grants the drug what is known as "priority review."

If car­filz­o­mib is granted priority review, the FDA will aim to make a decision on the application by the …

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[ by Melissa Cobleigh and | Oct 19, 2011 12:55 pm | 11 Comments ]

Earlier this year, an inter­na­tional group of myeloma experts pub­lished a review of ongoing re­search into new myeloma treat­ments.  This review not only described a wide range of po­ten­tial new myeloma treat­ments, but also in­cluded the experts' thoughts on where re­search into new treat­ments should go in the future.

Given the recent new drug appli­ca­tion for car­filz­o­mib and the upcoming annual meeting of the American Society of He­ma­tol­ogy -- which undoubtedly will host dis­cus­sions of many po­ten­tial new myeloma treat­ments -- it seems an appro­pri­ate time to go back to the experts' review from …

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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 …

NewsFlash »

Reduced-Dose Velcade-Thalidomide-Dexamethasone Is Effective For Newly Diagnosed Myeloma – Recently published results from a French study show that the com­bi­na­tion of reduced-dose Velcade (bor­tez­o­mib) and thalidomide (Thalomid) plus dexamethasone (Decadron) is safer and more effective than standard-dose Velcade plus dexa­meth­a­sone for the treat­ment of newly diagnosed multiple myeloma patients. The results were pre­vi­ously presented at the American Society of Clinical Oncology (ASCO) meeting in June 2010. Results showed that after four cycles of ther­apy, patients who received the reduced-dose three-drug com­bi­na­tion had a significantly higher response rate and experienced fewer side effects than patients receiving the standard-dose regi­men. The same group of patients con­tinued to have a higher response rate after stem cell trans­planta­tion. For a more detailed summary of the results, please see the Beacon’s coverage of the ASCO presentation or the study in the journal Blood (abstract).

Phase 3 Clinical Trial Investigating The Need For Stem Cell Transplantation Is Recruiting Myeloma Patients – Newly diagnosed multiple myeloma patients under the age of 65 years are being recruited at various cancer centers across the United States for a Phase 3 clinical trial that will in­ves­ti­gate whether stem cell trans­plants are necessary in the era of novel agents.  All participants will be treated with a com­bi­na­tion of Revlimid (lena­lido­mide), Velcade, and dexa­meth­a­sone.  Half of the patients will then also receive a stem cell trans­plant.  Based on the results, researchers will determine whether stem cell trans­planta­tion sig­nificantly extends pro­gres­sion-free survival. For more in­­for­ma­tion or to enroll, please see the clinical trial description.

Teleconference On Clinical Trial Participation – On Thursday, the Inter­na­tional Myeloma Foundation will sponsor a teleconference about the importance of participating in clinical trials.  Dr. Brian Durie, a myeloma specialist at Cedars-Sinai Cancer Center, will discuss the Phase 3 clinical trial comparing carfilzomib-Revlimid-dexamethasone and Revlimid-dexamethasone alone.  The call will be held from 4 p.m. to 5 p.m. PT.  For more in­­for­ma­tion, please see the International Myeloma Foundation website.

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.

NewsFlash »

Protein May Interfere With Revlimid Doses In The Body – Results of a recent small Phase 1 clinical trial investigating the efficacy and safety of Revlimid (lena­lido­mide) in com­bi­na­tion with Torisel (temsirolimus) suggest that P-glycoprotein, a protein that causes the removal of certain drugs from cells into the bloodstream, interferes with Revlimid dosing. High levels of P-glycoprotein in cancer cells may be the cause of drug resistance. The researchers observed higher than expected concentrations of Revlimid in the patients’ bloodstreams. Experiments in the lab showed that P-glycoprotein removed Revlimid from the cancer cells. The experiments also showed that the rate of removal was lower when Torisel was added to the experiments, which, according to the study authors, is evidence that the two drugs inter­act via P-glycoprotein. For more in­­for­ma­tion, please see the study in the Journal of Clinical Oncology (abstract) or the Ohio State University Medical Center press release.

Phase 2 Trial Of Carfilzomib For Multiple Myeloma Is Recruiting Patients – The Multiple Myeloma Clinical Research Section at the National Cancer Institute is recruiting participants for a Phase 2 trial to test the effectiveness of the investigational drug carfilzomib in com­bi­na­tion with Revlimid and dexamethasone (Decadron) in newly-diagnosed multiple myeloma patients. Patients will receive eight 28-day treat­ment cycles. Those who show at least stable disease after the treat­ment may con­tinue to receive 12 cycles of low-dose Revlimid main­te­nance ther­apy. In addi­tion to current standard, clinical methods for determining responses to the drugs, the researchers will use new molecular methods to assess response and to detect minimal residual disease. To par­tic­i­pate in the trial, please contact the research nurse, Mary Ann Yancey, at (301) 435-9227 or .

Chicago Area Workshop For Multiple Myeloma Patients – The Multiple Myeloma Research Foundation will hold a one-day educational workshop for myeloma patients and their family members on August 20 in Oak Brook, IL. The pro­gram will be led by Dr. Todd Zimmerman, a myeloma expert from the University of Chicago Medical Center. Throughout the day, myeloma experts will talk about treat­ments options for newly diagnosed and re­lapsed/refractory patients, including stem cell trans­plants, supportive care options, and clinical trials.  The specialists will also be available to answer questions.  Registration will begin at 9 a.m., and the pro­gram will last from 10 a.m. until 3:30 p.m. at the Hamburger University at the Hyatt Lodge. For more in­­for­ma­tion or to register, please see the Multiple Myeloma Research Foundation website. 

For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.