Celgene, the company that markets Revlimid in the United States and inter­nationally, announced this morning that it has withdrawn its applica­tion in Europe to have the drug approved for use as initial therapy for newly diagnosed myeloma patients as well as for maintenance therapy.

The company also is postponing until next year a similar application it had intended to file in 2012 with the U.S. Food and Drug Administration (FDA).

The European application was withdrawn due to concerns raised by …

Celgene Corporation announced this morning that the U.S. Food and Drug Administration (FDA) has granted “standard review designation” to the company’s new drug application for pomalidomide.

This designation means that the FDA expects to make a decision by February 10, 2013, on Celgene’s application to market pomalidomide (Pomalyst) in the United States.

Celgene (NASDAQ:CELG) also confirmed this morning that a marketing authorization application for pomalidomide has been submitted to the European Medicines Agency (EMA), meaning pomalidomide could be approved for use …

The Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) has voted 11 to zero with one abstention in favor of car­filz­o­mib's bid to be approved as a new treat­ment for multiple myeloma.

Specifically, the majority of the committee voted that the risk-benefit assess­ment for carfilzomib (Kyprolis) is favorable for the treat­ment of patients with re­lapsed and refractory multiple myeloma who have received at least two prior lines of ther­apy.

Today's vote by the FDA …

The Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) met today to discuss and vote on the new drug application for carfilzomib (Kyprolis).

The committee, often referred to as the ODAC, reviewed data on the efficacy and safety of car­filz­o­mib that the FDA released for the committee members on Monday (see related Beacon news) and then voted on whether car­filz­o­mib’s benefit risk profile was favorable for the treat­ment of multiple myeloma.

Myeloma Beacon staff members …

Each of us has his or her own way of dealing with multiple myeloma and cancer.

I was reminded of this when I read a recent column here at The Myeloma Beacon by Dr. Arnie Goodman.  I hope you all read it.

From following Dr. Goodman’s columns of late, you’d know he hasn’t been in a particularly good way in his personal myeloma battle for some time now.  Right now he’s in a difficult place.

He’s in a position …

U.S. Food and Drug Administration (FDA) staff members appear to have substantial concerns related to the safety of car­filz­o­mib.

The FDA this morning published its internally prepared briefing document for this Wednesday's meeting of the agency's Oncologic Drugs Advisory Committee (ODAC) (see related Beacon news).

At that meeting, the committee will review data related to Onyx Pharma­ceutical's (NASDAQ:ONXX) application to have carfilzomib (Kyprolis) approved as a new treat­ment for re­lapsed / refractory multiple myeloma.

The FDA report released …

The U.S. Food and Drug Administration this morning released addi­tional in­­for­ma­tion related to its Oncologic Drugs Advisory Committee meeting scheduled for this Wednesday, when the committee will review data related to the application by Onyx Pharmaceuticals (NASDAQ:ONXX) to have car­filz­o­mib approved as a new treat­ment for multiple myeloma.

In addi­tion to a draft agenda and draft committee roster, the Food and Drug Administration (FDA) released briefing in­­for­ma­tion for the committee members and a question about the risk/benefit profile …