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Celgene Gets EC Nod for Label Expansion of Revlimid, Imnovid

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Celgene Corporation CELG announced that the European Commission (EC) has approved the label expansion of IMiD medications: leading oncology drug Revlimid (lenalidomide) and Imnovid.

The EC approved Revlimid in combination with Velcade and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The approval for RVd was supported by data from SWOG S0777, a phase III trial evaluating the triplet combination, RVd, in adult patients with previously untreated multiple myeloma.

The commission also approved Imnovid in combination with Velcade and dexamethasone (PVd) for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

The approval of PVd was supported by data from OPTIMISMM study, which evaluated the regimen in patients who were previously treated with Revlimid.

An approval was in the cards as the CHMP had recommended approval of the same last month.

The new triplet regimens should improve outcomes for both newly diagnosed patients as well as those who have relapsed or become refractory to first-line therapy. Thus, sales should get a boost. Celgene's key growth driver, Revlimid, an oral immunomodulatory drug, is currently approved for several indications, including multiple myeloma, myelodysplastic syndromes and mantle cell lymphoma.  Net sales of Revlimid came in at $2.6 billion in the first quarter, reflecting 15% year-over-year increase.

Celgene's stock has gained 49.1% in the year so far compared with the industry's rise of 2.4%.


Celgene has been in the news for its impending merger with Bristol-Myers Squibb Company BMY. In January, Bristol-Myers had announced that it will acquire Celgene for approximately $74 billion.

The merger is expected to close in the third quarter.

The acquisition announcement prompted quite a few other deals. Another leading biotech, Biogen (BIIB - Free Report) announced that it will acquire Nightstar Therapeutics. Swiss pharma giant, Roche RHHBY announced that it will acquire Spark Therapeutics for $5 billion.

Zacks Rank

Celgene currently carries a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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