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FDA expands approval of Revlimid to include newly diagnosed multiple myeloma


FDA expanded approval of lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma. Revlimid acts as an immunomodulating agent and inhibits the growth of myeloma cells by inducing cell cycle arrest and cell death.

FDA has expanded its approval of the immunomodulator lenalidomide (Revlimid; Celgene), an oncological agent used in combination with dexamethasone, to include the treatment of newly diagnosed multiple myeloma.

The American Cancer Society estimates that about 26,850 new cases of multiple myeloma will be diagnosed and about 11,240 people will die from multiple myeloma in 2015.

Revlimid acts as an immunomodulating agent and inhibits the growth of myeloma cells by inducing cell cycle arrest and cell death. The drug is available as an oral capsule given in combination with dexamethasone to treat multiple myeloma.

Related: Updated data with oral proteasome inhibitor reported in newly diagnosed multiple myeloma patients

Previously, the drug was approved for patients who had already received at least one therapy. The expanded FDA approval permits treatment of newly diagnosed patients. As physicians in the United States have long been prescribing Revlimid for new patients as an “off-label” use, the approval is expected to increase sales in the United States only modestly.


FDA’s approval was based on safety and efficacy results from a randomized multicenter, open-label trial involving patients with newly diagnosed multiple myeloma as well as two randomized clinical studies of patients with previously treated multiple myeloma. The primary end point was the time from randomization to disease progression or death.

In the study of patients with newly diagnosed multiple myeloma, 1,623 patients were randomly assigned to one of three treatments:

  • Revlimid and low-dose dexamethasone (Rd) given continuously until disease progression,

  • Rd given for up to 18 cycles of 28 days (72 weeks),

  • Melphalan, prednisone, and thalidomide (MPT) for up to 12 cycles of 42 days (72 weeks).

“PFS [Progression-free survival] was significantly longer with Rd Continuous than MPT: HR 0.72….A lower percentage of subjects in the Rd Continuous arm compared with the MPT arm had PFS events (52% versus 61%, respectively,” the package insert stated. “The improvement in median PFS time in the Rd Continuous arm compared with the MPT arm was 4.3 months.”

In the trials of patients with previously treated multiple myeloma, the first study demonstrated a median survival time of 39.4 months in the Rd group and 31.6 months in the placebo/dexamethasone group (HR 0.79). In the second study, the patients treated with Rd had a median survival time of 37.5 months and the placebo/dexamethasone group had 30.8 months median survival time (HR 0.86).

With the expanded approval, Celgene can now market Revlimid, in combination with dexamethasone, as treatment for all multiple myeloma patients.

“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, Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women’s Cancer Center. “We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival.”

Revlimid is also approved in the United States for the treatment of myelodysplastic syndromes as well as for patients with mantle cell lymphoma whose disease has progressed after two prior therapies.


Revlimid, a thalidomide analogue, carries a boxed warning of embryo-fetal toxicity, hematologic toxicity, and venous and arterial thromboembolism.

Female patients must use two reliable forms of contraception during treatment, and before the therapy is initiated, they must be screened to ensure that they are not pregnant. To prevent embryo-fetal exposure to lenalidomide, Revlimid is available only through a restricted distribution program, the Revlimid REMS program.

The drug also can cause significant neutropenia and thrombocytopenia. Patients with del 5q myelodysplastic syndromes must be monitored with complete blood counts weekly for the first eight weeks of treatment and then monthly for the duration of treatment.

Patients taking Revlimid and dexamethasone must also consider anti-thrombotic prophylaxis because the drug treatment has been shown to significantly increase the risk of deep vein thrombosis and pulmonary embolism (PE), as well as the risk of stroke and heart attack.

The most commonly reported adverse reactions (≥20%) associated with Revlimid in patients with multiple myeloma include diarrhea, anemia, neutropenia, peripheral edema, fatigue, back pain, muscle cramps and spasms, nausea, asthenia, pyrexia, upper respiratory tract infection, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, tremor, and insomnia. 

Erin Bastick is a 2016 PharmD Candidate, Ohio Northern University, and an inpatient intern at University Hospitals in Cleveland.

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