FDA Expands Multiple Myeloma Drug Use

Celgene today announced that the FDA has granted an expanded use approval for its multiple myeloma drug, lenalidomide (Revlimid).

The expanded use of lenalidomide in combination with dexamethasone is for patients newly diagnosed with multiple myeloma. The combination of lenalidomide with dexamethasone was previously approved in 2006 for the treatment of multiple myeloma in patients who received at least 1 prior therapy.

"The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease," said Kenneth Anderson, MD, director of the Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women's Cancer Center, in a press release. "We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival."

The approval follows various phase 3 trials, including the FIRST study that evaluated continuous lenalidomide in combination with dexamethasone (Rd Continuous) until disease progression compared with melphalan, prednisone, and thalidomide (MPT) for an 18-month duration. The trial also included a fixed duration of 18 cycles of Rd as a secondary analysis in 1623 newly diagnosed patients who were not candidates for stem cell transplant.

The randomized, open-label, 3-arm trial found that median progression-free survival was 25.5 months among patients receiving Rd Continuous, while progression-free survival with MPT was 21.2 months. Median overall survival in the Rd Continuous group was 58.9 months, compared with 48.5 months in the MPT group.

Patients in the Rd Continuous arm experienced a 25% reduction in the risk of death compared with patients in the MPT arm.

Adverse events in both groups included diarrhea, anemia, neutropenia, fatigue, back pain, insomnia, asthenia, rash, decreased appetite, cough, pyrexia, muscle spasms, and abdominal pain.

The most frequently reported adverse events in the Rd Continuous arm until disease progression included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract, dyspnea, DVT, and hyperglycemia.

"At Celgene, we are very happy with the FDA's decision, which adds information on the use of Revlimid plus dexamethasone as a first-line treatment for multiple myeloma to the prescribing information," said Jacqualyn A. Fouse, PhD, president of Global Hematology and Oncology for Celgene, in a press release. "Now, as part of our commitment to improving the lives of patients living with this disease, our next step is to make the benefits of this treatment regimen available to those now eligible under the expanded indication."