Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG) today announced that the European Com­mis­sion (EC) has granted approval for Poma­lido­mide Celgene^® (poma­lido­mide), in com­bi­na­tion with dexa­meth­a­sone, for the treat­ment of re­lapsed and refractory multiple myeloma (rrMM) in adult patients who have received at least two prior ther­a­pies in­­clud­ing both lena­lido­mide and bor­tez­o­mib and have dem­onstrated disease pro­gres­sion on the last ther­apy.¹ Celgene intends to launch Poma­lido­mide Celgene in the EU under the trade name “IMNOVID^®”, fol­low­ing sub­mission of a regu­la­tory notification to the European Medicines …

An advisory committee of the European Medicines Agency has issued a positive opinion regarding European approval of pomalidomide for the treatment of cer­tain patients with multiple myeloma.

Specifically, the Committee for Medicinal Products for Human Use (CHMP) rec­om­mended that pomalidomide be approved for use in com­bi­na­tion with dexa­metha­sone (Decadron) for the treatment of re­lapsed and refractory multiple myeloma patients who have received at least two prior therapies, including both Revlimid (lenalidomide) and Velcade (bor­tezo­mib), and have demonstrated disease progression while on their last therapy.

The …

During a session at the International Myeloma Workshop (IMW) held in Japan last week, Dr. Keith Stewart from the Mayo Clinic summarized the latest findings from research related to the protein cereblon and its im­pact on certain myeloma treatments.

Dr. Stewart reported that low levels of cereblon are associated with lower re­sponse rates and reduced survival outcomes in multiple myeloma patients treated with the immunomodulatory agents Revlimid (lena­lido­mide), thalidomide (Thalomid), and Pomalyst (pomalidomide).

He explained that, with further investigation, these findings may eventually help physicians customize ther­apy …

A sub-analysis of recent Phase 2 clinical trial results indicates that Pomalyst in combination with low-dose dexamethasone is effective and safe in multiple myeloma patients with high-risk chromosomal ab­nor­malities who did not re­spond to prior therapy.

The findings were presented by Dr. Paul Richardson of the Dana-Farber Cancer Institute in Boston at the International Myeloma Workshop (IMW) in Kyoto, Japan, this past Sunday.

In the new analysis, high-risk patients were defined as those with a deletion in chromosome 17 (del17p) or the translocation t(4;14).

Although the response rates were lower and survival times shorter …

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 …

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 announced this morning that it plans to submit an application for the approval of pomalidomide for relapsed and refractory multiple myeloma to the U.S. Food and Drug Administration (FDA) during the first quarter of 2012.

In addition, the company said that it plans to submit a similar application to the European Medicines Agency (EMA) during the first half of this year.

The updated submission timeline means that pomalidomide could be approved for use in the United States and in Europe by the end of this year.

Celgene's announcement was made in a …