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 …

Physicians in the United States are able to prescribe Kyprolis for their patients now that the drug has been approved for the treat­ment of multiple myeloma.

The drug's widespread availability, however, raises the important question: For what types of myeloma patients are physicians likely to prescribe Kyprolis?

Last month, the U.S. Food and Drug Administration (FDA) approved Kyprolis (car­filz­o­mib) for the treat­ment of multiple myeloma patients meeting specific criteria. The patients must have received at least two prior ther­a­pies, …

Results from a recent retrospective study con­firm that treat­ment with a com­bi­na­tion of Revlimid and dexa­meth­a­sone slows disease pro­gres­sion and im­proves survival in elderly patients with re­lapsed or refractory myeloma.

However, findings from the study also indicate that certain side effects, such as anemia and blood clots, occurred more frequently in elderly patients.

Novel agents such as Revlimid (lena­lido­mide), thalidomide (Thalomid), and Velcade (bor­tez­o­mib) are commonly used to treat re­lapsed and refractory myeloma.

A pre­vi­ous study found …

A recent study demonstrates that better treatments are still needed for multiple myeloma patients who develop extramedullary disease.  Specifically, the results show that these patients have poorer progression-free survival and overall survival compared to patients without extramedullary disease.

The results also show that extramedullary disease is more common in patients with high-risk multiple myeloma.

Extramedullary disease occurs when multiple myeloma cells develop in the soft tissues and organs outside of the bone marrow. It can occur in newly diagnosed myeloma, …

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 …

Results of a recent Phase 3 study suggest that preventative treatment with certain oral antibiotics does not significantly decrease the rate of bacterial infections among newly diagnosed multiple myeloma patients receiving initial treatment.

In the study, myeloma patients who received prophylactic (preventative) antibiotics during the first two months of chemotherapy experienced statistically similar rates of infections during those two months and for up to two years following chemotherapy as patients who did not receive antibiotics.

“Unfortunately, prophylactic antibiotics did not …

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 …