Last week, the U.S. Food and Drug Administration (FDA) approved Kyprolis (car­filz­o­mib) 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.

What exactly did the FDA approve?

The FDA approved Kyprolis for the treat­ment of multiple myeloma patients meeting specific criteria.  The patients must have received at least two prior ther­a­pies.  These two ther­a­pies must have included Velcade (bor­tez­o­mib) and an …

The United States Food and Drug Administration (FDA) has approved carfilzomib, which will be marketed under the brand name Kyprolis, for the treat­ment of people with multiple myeloma who have received at least two prior ther­a­pies.

Specifically, Kyprolis has been approved for myeloma patients who have already been treated with at least Velcade (bor­tez­o­mib) and either Revlimid (lena­lido­mide) or thalido­mide (Thalomid) and who have also progressed on or within 60 days of completing their last ther­apy.

“I am very pleased,” said Dr. Vincent Rajkumar from the …

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the company that markets Revlimid in the United States and inter­nationally, announced this morning that it has withdrawn its applica­tion in Europe to have the drug approved for use as initial therapy for newly diagnosed myeloma patients as well as for maintenance therapy.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The European application was withdrawn due to concerns raised by regulators about the link between Revlimid (lenalidomide) and second cancers (also known as second …

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 in Europe by the end of 2012 or early 2013.

Pomalidomide belongs …

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 committee went much better for car­filz­o­mib than had been expected.   A …

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 provided live updates below as the ODAC meeting progressed.

1 p.m.: The car­filz­o­mib …

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 this morning states that the agency's staff is "very concerned" about "severe …