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 …

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 …

Results from a number of clinical trials studying car­filz­o­mib for the treat­ment of multiple myeloma were presented at the 2012 American Society of Clinical Oncology (ASCO) annual meeting last weekend.

Findings from three Phase 1/2 clinical trials showed that several carfilzomib (Kyprolis) com­bi­na­tions are effective for newly diagnosed multiple myeloma patients. Researchers involved in each of these clinical trials presented the results during oral presentations at the ASCO meeting.

In addi­tion, early results from several clinical trials presented at the meeting con­tinue to show that car­filz­o­mib …

This year’s American Society of Clinical Oncology (ASCO) annual meeting, which is being held in Chicago, began on Friday and goes through tomorrow. How­ever, to­day is the last day with any myeloma-related sessions.

Several myeloma-related oral pre­sen­ta­tions were given this morn­ing and were summarized in an up­date pub­lished earlier to­day (see re­lated Beacon news).

This afternoon featured a poster session in which im­por­tant new re­search findings were summarized on posters throughout a large conference hall.

The stud­ies pre­sented this afternoon were on a wide variety of myeloma-related topics ranging from new treat­ments …