Interim results from a Phase 3 clinical trial indicate that pomalidomide plus low-dose dexamethasone extends the progression-free and overall survival of relapsed and refractory multiple myeloma patients, as compared to high-dose dexamethasone alone.

The results are from a European clinical trial known as MM-003.  The trial includes multiple myeloma patients who relapsed or did not respond to at least two prior therapies.  Half of the patients were treated with poma­lido­mide (Pomalyst) plus low-dose dexamethasone (Decadron), and the other half were treated with high-dose dexamethasone alone.

A data safety …

The U.S. Food and Drug Administration (FDA) has canceled the November advisory committee meeting during which Celgene's application to have pomalidomide (Pomalyst) approved as a new multiple myeloma treatment was scheduled to be reviewed.

The meeting of the advisory committee -- formally known as the Oncologic Drugs Advisory Committee (ODAC) -- was placed on the FDA schedule just last month (see related Beacon news).

The cancellation of the ODAC meeting does not necessarily mean there has been any change in either the FDA's overall schedule for reviewing pomalidomide's new drug …

Celgene 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 pomalidomide.

Celgene (NASDAQ: CELG) has applied to the Food and Drug Administration (FDA) to have pomalidomide (Pomalyst) approved, in combination with dexamethasone(Decadron), for the treatment of patients with relapsed and refractory multiple myeloma that has progressed after 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 …

Pomalidomide continues to show promise as a treatment for relapsed or refractory multiple myeloma patients, according to updated results from two recent Phase 2 clinical trials.

Findings from the two trials were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago earlier this month.

“Pomalidomide has been tested in multiple clinical trials … and responses were between 30 percent to up to 65 percent when patients had one to three prior lines of therapy. Most interestingly, this agent is showing responses even in patients who are [resistant to] …

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 …

Results from many important multiple myeloma studies were presented this morning during the third day of the American Society of Clinical Oncology (ASCO) annual meeting.  Most of the talks were about potential new anti-myeloma drugs.

This update will summarize the presentations about carfilzomib (Kyprolis) and pomalidomide (Pomalyst), two of the most promising new treat­ments being developed for multiple myeloma.  Both of these drugs have been submitted to the U.S. Food and Drug Administration for potential approval as new myeloma treat­ments.

Carfilzomib

The first three presentations were about car­filz­o­mib. …

This year’s American Society of Clinical Oncology (ASCO) annual meeting, which is being held in Chicago, began yesterday and goes through Tuesday.

The first of the myeloma-related sessions at this year's meeting began this morning with a poster session, in which important new research findings were summarized on posters throughout a large conference hall.

MLN9708

This morning’s session included two posters about MLN9708 (ixazomib), an oral drug that works similarly to Velcade (bor­tez­o­mib) and is being in­ves­ti­gated for the treat­ment of multiple myeloma as well as …