Recently Celgene Corporation (CELG) received some encouraging news when the European Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits associated with Celgene’s Revlimid outweighed the risks in patients suffering from multiple myeloma (MM).
The CHMP reached the decision after conducting a safety review (article 20) of Revlimid in combination with dexamethasone in MM patients who have received at least one prior therapy. We note that an article 20 review refers to the process by which the European Commission (EC) reassesses the risk-benefit profile of a centrally authorized product in an indication already approved in the European Union.
The safety review was conducted following reports of second primary malignancies (SPM) associated with Revlimid in clinical studies. The analysis revealed that the rate of SPMs observed in the studies was low and not unexpected in the patient population targeted by the drug. The CHMP has asked Celgene to update the label of Revlimid to include information on SPMs.
The positive news is highly encouraging for Celgene since Revlimid is the company’s key growth engine. Revlimid is approved in approximately 70 countries across the globe in combination with dexamethasone for treating MM patients who have received at least one prior therapy.
Revlimid is also available in many countries for treating transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndrome (MDS) associated with a deletion 5q cytogenetic abnormality (with or without additional cytogenetic irregularities).
Celgene is seeking to expand Revlimid’s label into other indications. The company is seeking approval for Revlimid as a front-line maintenance treatment for MM in Europe. The positive review by the CHMP regarding Revlimid could help in Celgene’s label expansion efforts. US approval is expected to be sought later in the year.
Our Recommendation
Celgene, which focuses on the discovery, development and commercialization of novel drugs for treating cancer and inflammatory diseases, carries a Zacks #2 Rank (Buy rating) in the short run. Currently, we have a ‘Neutral’ stance on the stock in the long run.
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