Celgene Corp’s cancer drug Revlimid (lenalidomide) met its main goal in the drug’s phase III late-stage trial, meaning that the medication is one step closer to being approved for new cases of multiple myeloma.
Multiple myeloma is also known as plasma cell myeloma. It is a form of cancer that affects the plasma cells – white blood cells found in the bone marrow. Plasma cells are important because they help produce antibodies which fight off infections.
According to the American Cancer Society there will be around 22,350 new cases of multiple myeloma this year and over 10,000 deaths.
Revlimid is currently approved for treating patients with multiple melanoma who haven’t had success with previous therapies. However, Celgene strongly believes that the drug has the potential to be used for a wider range of cases.
Last year, the company withdrew its submission in Europe for approval of the drug in treating newly diagnosed multiple myeloma (blood cancer) patients.They decided to withdraw because the EU’s Committee for Medicinal Products for Human Use insisted on more mature data on the benefits and risks of the medication.
The trial tested the effectiveness of the drug in patients who were newly diagnosed with multiple myeloma.
Celgene said the trial included “1,623 patients who were ineligible for autologous stem cell transplantation to receive continuous oral lenalidomide plus low-dose dexamethasone until disease progression; lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72 weeks); or melphalan, prednisone and thalidomide for up to twelve 42-day cycles (72 weeks).”
The researchers found that, when combined with dexamethasone, Revlimid is capable of significantly improving the survival rate in patients newly diagnosed with multiple myeloma.
The company will begin discussing plans to submit dossiers for approval registration in the U.S. and Europe.
Analysts believe that these results significantly increase the probability that the drug will be approved for the treatment of patients with newly-diagnosed multiple myeloma in the European and American markets.
Revlimid is predicted to bring in annual sales of $4.2 billion this year and 5.35 billion in 2015 (according to Thomson Reuters Pharma). Following the announcement of the trial results, the company’s shares went up 7 percent.