Celgene Corporation (CELG) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion for continuous oral treatment with Revlimid in treatment naïve adults suffering from multiple myeloma who are not eligible for stem cell transplantation. A final decision from the European Commission is expected in approximately two months.
Revlimid is already approved in many countries across the globe in combination with dexamethasone for treating multiple myeloma patients, who have received at least one prior therapy. Revlimid is also approved in the U.S. in the relapsed refractory mantle cell lymphoma indication.
Revlimid is also available in many countries for treating transfusion-dependent anemia due to low or intermediate-1-risk myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality (with or without additional cytogenetic irregularities). Celgene is looking to expand the drug’s label.
Our Take
We are pleased with CHMP’s positive recommendation for Revlimid in the treatment naïve multiple myeloma indication. We note that the European Commission generally follows the CHMP recommendation. We believe that the label expansion will boost the drug’s sales potential.
As per the National Cancer Institute, it is estimated that approximately 24,050 new cases of multiple myeloma will occur in 2014 in the U.S. alone. Currently approved drugs for multiple myeloma include Amgen Inc.’s (AMGN) Kyprolis and Johnson & Johnson’s (JNJ) Velcade.
Celgene carries a Zacks Rank #2 (Buy). A better-ranked stock in the biopharma space is Amgen and Biogen Idec Inc. (BIIB), both sporting a Zacks Rank #1 (Strong Buy).
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