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 of carfilzomib (Kyprolis) that the advisory committee will discuss and vote …

Carfilzomib has an important date next week.

An advisory committee to the U.S. Food and Drug Administration (FDA) will meet next Wednesday to review data about car­filz­o­mib's efficacy and safety.  The review will focus, in particular, on clinical trial results for carfilzomib (Kyprolis) as a treat­ment for re­lapsed and refractory multiple myeloma patients.

At the end of the meeting, the committee will vote whether or not to recommend that the FDA approve car­filz­o­mib as a new myeloma treat­ment.

A Beacon survey of financial analysts who follow the stock of …

The U.S. Food and Drug Administration earlier today issued an extensive update regarding the risk of developing a second cancer while being treated with Revlimid.

The update comes on the heels of a change the Food and Drug Administration (FDA) made to the prescribing information for Revlimid (lenalidomide) in March of this year.

The change involved the addition of a warning that patients being treated with Revlimid have an increased risk of developing a second cancer (see related Beacon news).

Today’s update by the FDA includes more specific details of the …

Onyx Pharmaceuticals has proposed ‘Kyprolis’ as the trademarked brand name for car­filz­o­mib.  The name was announced this morning by the U.S. Food and Drug Administration (FDA).

The FDA con­firmed in the announcement that the agency’s Oncologic Drugs Advisory Committee, which advises the FDA during its review of potential new cancer drugs, will discuss the new drug application for Kyprolis (carfilzomib) on June 20.  Onyx (NASDAQ: ONXX), the com­pany developing car­filz­o­mib, announced the review date last week (see related Beacon news).

The official use of carfilzomib that the committee …

Onyx Pharmaceuticals announced this morning that the U.S. Food and Drug Administration has set a date for an advisory committee meeting to review the com­pany’s application for approval of car­filz­o­mib.

Onyx (NASDAQ: ONXX) has applied to the Food and Drug Administration (FDA) to have carfilzomib (Kyprolis) approved for treat­ment of re­lapsed and refractory multiple myeloma patients who have had at least two prior ther­a­pies.

The Oncologic Drugs Advisory Committee (ODAC), which advises the FDA regarding the potential approval of new cancer drugs, will meet on June 20 to review the  carfilzomib application. …

Celgene Corporation announced this morning that it has completed submission of its application to the U.S. Food and Drug Administration (FDA) for the approval of pomalidomide as a treatment for relapsed and refractory multiple myeloma.

If the FDA approves pomalidomide based on this application, Celgene could begin marketing pomalidomide in the United States as early as this fall.

Pomalidomide (Pomalyst), which belongs to the same class of drugs as thalidomide (Thalomid) and Revlimid (lenalidomide), is being developed by Celgene (NASDAQ: CELG) for the treatment of multiple myeloma and myelofibrosis.

Results from …

The U.S. Food and Drug Administration has added a warning to the prescribing information for Revlimid stating that patients being treated with the drug have an increased risk of developing a second cancer.

The warning has been added in two parts of the prescribing information.

In the upfront ‘Warnings and Precautions’ section, text has been included stating that “Higher incidences of SPM [second primary malignancies] were observed in controlled trials of patients with multiple myeloma receiving Revlimid.”

Later in the document, the warning is expanded to explain that studies have shown that multiple …