Celgene falls on Revlimid setback

Celgene Corp. (NASDAQ:CELG) fell $7.72 (11%) to $59.45 on Thursday after withdrawing a European application to extend the label of multiple myeloma drug Revlimid lenalidomide. According to Celgene, EMA's CHMP needs more mature data before it can make a benefit-risk decision on the application, which is seeking approval of Revlimid as maintenance treatment in newly diagnosed MM patients who have not progressed following initial treatment, or as maintenance therapy following autologous stem cell transplantation. Celgene said the committee expressed concerns about the potential effect of second primary malignancies on survival. Celgene plans to evaluate long-term follow-up data every three months from the three ongoing Revlimid trials included in the submission. The company said it will reexamine within the next 3-6 months the opportunity for resubmission. The stock move translates to a decrease in market cap of $3.4 billion. Celgene's market cap is now $26.2 billion.

Celgene also said it is reevaluating its U.S. submission in the indication and expects to submit an application next year. Submissions in Switzerland and Australia are planned for this year. Celgene markets Revlimid in the U.S. and EU in combination with dexamethasone to treat MM in patients who have received at least one prior therapy and in the U.S. to treat patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS). ...