Celgene Corp.’s Revlimid, the company’s best-selling drug, won approval for wider use in patients with a rare and aggressive form of cancer called mantle cell lymphoma that starts in white blood cells.
The Food and Drug Administration cleared the drug for patients who have already been treated for the disease and have relapsed, the Summit, New Jersey-based company said today in a statement.
Revlimid is already cleared for multiple myeloma, another white blood cell cancer. The $3.8 billion drug, approved in 2005, may generate $5.9 billion in 2016, according to 14 analysts’ estimates compiled by Bloomberg.
Mantle cell lymphoma is a form of non-Hodgkin lymphoma, according to the Leukemia & Lymphoma Society. Patients use Takeda Pharmaceutical Co.’s Velcade and Roche Holding AG and Biogen Idec Inc.’s Rituxan, approved for non-Hodgkin lymphoma.
Celgene fell 4.7 percent to $112.20 at the close in New York. The company has gained 74 percent in the past 12 months.
Mantle cell lymphoma represents about 2 percent to 7 percent of adult non-Hodgkin lymphomas and primarily affects men older than 50, according to the National Organization for Rare Disorders. Almost 70,000 people are expected to be diagnosed and 19,000 will die from non-Hodgkin lymphoma this year.
Johnson & Johnson and Pharmacyclics Inc. are studying ibrutinib to treat mantle cell lymphoma patients who have received other treatment.
Celgene asked for approval based on data from the second of what are typically three phases of clinical trials.