Back to top

Celgene's Revlimid Gains EU Nod for Mantle Cell Lymphoma

Read MoreHide Full Article

Positive news flowed in at Celgene Corporation (CELG - Free Report) when the European Commission approved a label expansion of Revlimid. With the label expansion, Revlimid can now be used for the treatment of adults with relapsed or refractory mantle cell lymphoma (MCL).

EU approval was largely expected as the Committee for Medicinal Products for Human Use had issued a favorable opinion earlier this year. The approval was based on positive data from a phase II study (MCL-002) which evaluated the efficacy and safety of Revlimid versus the investigator's choice in patients who were refractory to their last treatment or had relapsed one to three times. Revlimid significantly improved progression-free survival of 8.7 months versus 5.2 months in the control arm.

Revlimid is expected to provide a new treatment option to patients living in the EU with relapsed/refractory MCL. Per the company’s press release, MCL is a rare sub-type of aggressive non-Hodgkin's lymphoma (NHL) with 3–6% of NHL patients suffering from MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes with fewer than 50% of patients surviving at 5 years.

We are encouraged by the label expansion of Revlimid. Revlimid is the key growth driver at Celgene. In 2015, Revlimid recorded global sales of $5.8 billion, reflecting an increase of 16.5%. Label expansion should boost the drug’s sales further.

We note that Revlimid is already approved in the U.S. for the treatment of patients with relapsed/refractory MCL. It is also approved in several countries including the EU for the treatment of newly diagnosed and relapsed/refractory multiple myeloma and myelodysplastic syndromes. Meanwhile, Celgene is working on expanding Revlimid’s label further.

Celgene is currently a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Fibrocell Science, Inc. (FCSC - Free Report) , Innoviva, Inc. (INVA - Free Report) and Merrimack Pharmaceuticals, Inc. . All three stocks carry a Zacks Rank #1 (Strong Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>


In-Depth Zacks Research for the Tickers Above


Normally $25 each - click below to receive one report FREE:


Celgene Corporation (CELG) - free report >>

Fibrocell Science Inc (FCSC) - free report >>

Innoviva, Inc. (INVA) - free report >>