Articles tagged with: Pomalyst

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[ by | Mar 22, 2013 2:52 pm | 4 Comments ]
The Top Myeloma Research Of 2012

Looking back at all that has hap­pened in the world of mul­ti­ple myeloma since Jan­u­ary of 2012, it is hard not to be impressed by the many im­por­tant devel­op­ments that took place.

There is the obvious fact that, during that time, not one, but two new drugs to treat myeloma were approved by the U.S. Food and Drug Adminis­tra­tion (FDA).  Prior to 2012, the FDA had not approved a novel anti-myeloma ther­apy in over six years.

Yet 2012 was meaningful to the myeloma com­munity for reasons beyond the ac­­tiv­ity at the FDA’s …

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[ by | Mar 19, 2013 11:53 am | Comments Off ]
Kyprolis-Revlimid-Dexamethasone Combination Added To NCCN Guidelines As Upfront Therapy For Myeloma

The National Comprehensive Cancer Network (NCCN) recently released an updated version of its guidelines for the diag­nosis and treat­ment of multiple myeloma.

The most notable change to the guidelines is the addi­tion of Kyprolis (carfilz­omib), in com­bi­na­tion with Revlimid (lena­lido­mide) and dexa­metha­sone (Decadron), as an alter­na­tive treat­ment option for newly diagnosed myeloma patients eligible for a stem cell trans­plant.

The guidelines also now list Pomalyst (poma­lido­mide), in com­bi­na­tion with dexa­meth­a­sone, as a preferred salvage treat­ment for myeloma.

NCCN guidelines are followed closely by physicians and by many U.S. health …

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[ by | Feb 27, 2013 4:47 pm | 6 Comments ]
French Study Provides Further Insights Into Pomalyst's Efficacy, Safety, And Dosing

The results of a recent French Phase 2 study investigating two Pomalyst (poma­lido­mide) dosing schedules have been published.

The response, survival, and safety data from the study are in line with the results of other Pomalyst trials that have been made public over the past year or two.

In particular, the trial results indicate that the combination of Pomalyst plus low-dose dexamethasone is effective in multiple myeloma patients who have re­lapsed from, or are resistant to treatment with, Revlimid and Velcade.

Based on the data from this study and as …

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[ by | Updated: Feb 22, 2013 4:10 pm | 6 Comments ]
Pomalyst – Which Multiple Myeloma Patients Will Physicians Treat With It?

Now that Pomalyst has been approved in the United States as a treatment for multiple myeloma, the drug is available for physicians in the U.S. to prescribe for their patients.

The broad availability of Pomalyst, however, raises the important question: For what types of myeloma patients are physicians likely to prescribe Pomalyst?

Early this month, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) for the treatment of certain multiple myeloma patients.  These patients must have received at least two prior therapies, including Revlimid (lenalidomide) and Velcade (bortezomib), …

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[ by | Feb 13, 2013 1:17 pm | 15 Comments ]
Pomalyst - Questions And Answers About The FDA Approval

On Friday, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) 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.  The article is organized similarly to one the Beacon published about Kyprolis (carfilzomib) after it was approved by the FDA last summer.

What exactly did the FDA …

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[ by | Updated: Feb 8, 2013 9:20 pm | 20 Comments ]
Pomalyst (Pomalidomide) Approved By FDA For Relapsed And Refractory Multiple Myeloma

The United States Food and Drug Administration (FDA) has approved pomalidomide, which will be marketed under the brand name Pomalyst, for the treatment of relapsed and refractory multiple myeloma.

Specifically, Pomalyst has been approved for use in patients with multiple myeloma who have received at least two prior therapies including Rev­limid (lenalido­mide) and Velcade (bortezomib) and have demon­strat­ed disease progression on or within 60 days of completion of the last therapy.

Celgene (NASDAQ:CELG), the company that will market Pomalyst, has told The Beacon that the drug will be …

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[ by | Feb 8, 2013 10:45 am | Comments Off ]
Pomalidomide (Pomalyst) - The Waiting Game

The "what will the FDA decide about pomalidomide" waiting game is reaching its final hours, and the drama is peaking.

Celgene (CELG:NASDAQ), the company that has been developing poma­lido­mide, asked the U.S. Food and Drug Administration (FDA) last April to approve the drug for the treatment of relapsed and refractory myeloma.

Based on the date the company filed its new drug application with the FDA, the regulator is required to make a decision on the application by this coming Sunday, February 10.

Financial analysts are expecting a positive decision by …

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