The European Commission (EC) has approved pomalidomide ^[1] for the treatment of certain patients with multiple myeloma.  The European brand name for the drug is expected to be "Imnovid ^[2]," although final regu­la­tory approval of that name is still pending.

In the United States, pomalidomide is marketed under the brand name Poma­lyst ^[3].  It was approved earlier this year by the U.S. Food and Drug Ad­min­is­tra­tion (FDA) as a new treatment for myeloma.

The EC approved Imnovid for use in combination with dexamethasone ^[4] (Decadron) in patients with multiple myeloma who have received at least two prior therapies, including Revlimid ^[5] (lenalidomide) and Velcade ^[6] (bor­tezomib), and have demon­strat­ed disease progression on their last therapy.

The European approval follows the recommendation of a European Medicines Agency advisory committee, which in May issued a positive opinion in regard to approval of pomalidomide (see related Beacon ^[7] news).

The EC decision will allow Imnovid to be marketed as a treatment for the specified myeloma patients in all 27 countries of the European Union and in Norway, Iceland, and Liechtenstein.

The exact timing of Imnovid's availability in individual European coun­tries will depend, however, on when Celgene (NASDAQ: CELG), the com­pany that developed and markets Imnovid, decides to launch the drug in each country.

Celgene’s decisions in that regard will be affected, in part, by how long it takes the company to negotiate the drug’s pricing and/or reimbursement with national authorities.  Such nego­tia­tions can often take six months or longer to complete.

According to a spokesperson from Celgene, Imnovid most likely will be launched first in Germany, in ap­prox­i­mately one month.  Launches in other countries, such as France and Spain, are expected to followed a few months later.

Prior to Imnovid, the last Europe-wide approval of a novel myeloma therapy was in April, 2008, when the EC approved  thalidomide ^[8] (Thalomid) as a treatment for myeloma.  Kyprolis ^[9] (carfilzomib), another novel mye­loma therapy, was launched last year in the U.S. after its approval by the FDA in July 2012.  However, Onyx Pharmaceutical (NASDAQ: ONXX), the company that markets Kyprolis, has not yet filed for approval of the drug in Europe.

Imnovid is chemically similar to Revlimid ^[10] (lenalidomide) and thalidomide.  All three drugs are administered orally as a capsule or tablet, and the three drugs together make up the class of myeloma therapies known as immunomodulatory agents.

Celgene also markets Revlimid and thalidomide in the U.S. and internationally.

When asked to comment on Imnovid's European approval, Dr. Henk Lokhorst of the University Medical Cen­ter Utrecht in The Netherlands told The Beacon, "This is fantastic news for the doctors who treat myeloma patients and, especially, for patients, who have been waiting" for Imnovid's approval.

Dr. Antonio Palumbo, from the University of Torino in Italy, explained to The Beacon that he expects “lena­lido­mide [Revlimid] followed by pomalidomide [Imnovid] to amplify lenalidomide’s efficacy," such that Imnovid "can be considered an extension of lenalidomide therapy when lenalidomide becomes ineffective."

Imnovid’s EC approval is based on data from the Phase 3 “MM-003” clinical trial in relapsed and refractory myeloma patients. The study included 455 heavily pretreated myeloma patients and compared treatment with Imnovid plus low-dose dexamethasone to treatment with high-dose dexamethasone alone.

Patients in the Imnovid and low-dose dexamethasone arm of the MM-003 trial experienced a statistically longer progression-free survival (a median of 3.6 months) compared to the patients in the high-dose dexamethasone arm (1.8 months).

Updated results from that trial indicate that median overall survival was also significantly longer for patients treated with Imnovid (12.7) compared to those treated with dexamethasone alone (8.1 months).

Results from the MM-003 trial were last presented at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) meetings in June (see related Beacon ^[11] news; presentation ^[12] [pdf] courtesy of Dr. Katja Weisel).

In Imnovid’s clinical trials, the most frequent serious side effects were low red blood cell, white blood cell, and platelet counts, as well as infections such as pneumonia.

Until Imnovid is available in Europe, patients who qualify can receive Imnovid through clinical trials being conducted throughout Europe, including studies called STRATUS ^[13] and IFM2010-02 ^[14] (France).  An additional clinical trial will be opening in the United Kingdom; additional details about that trial will be available in 2014.

For more information about today’s EC approval of Imnovid, see the Celgene press release ^[15] and the official European prescribing information ^[16] for Imnovid.