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FDA approves Revlimid for myeloma maintenance after stem cell transplant
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The FDA today expanded the approval of lenalidomide to include maintenance therapy for patients with multiple myeloma who underwent autologous hematopoietic stem cell transplant.
Lenalidomide (Revlimid, Celgene) is the only FDA–approved treatment for maintenance after autologous HSCT.
“Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients. However, most patients will still see their disease recur or progress after this treatment,” Philip McCarthy, MD, director of the Blood and Marrow Transplant Center at Roswell Park Cancer Institute, said in a Celgene-issued press release. “Lenalidomide maintenance therapy, which has been shown to increase PFS following autologous stem cell transplant in clinical trials, can be considered a standard of care for these patients.”
The FDA based its approval on results of two studies that included more than 1,000 patients. The studies compared lenalidomide maintenance — administered until disease progression or unacceptable toxicity — with no maintenance.
PFS served as the primary efficacy endpoint in both studies.
In one study, researchers reported median PFS of 5.7 years among patients who received lenalidomide maintenance and 1.9 years among those who received no maintenance (HR = 0.38; 95% CI, 0.28-0.5).
In the second study, researchers reported median PFS of 3.9 years among those who received lenalidomide maintenance and 2 years among those who received no maintenance (HR = 0.53; 95% CI, 0.44-0.64).
Although individual studies were not powered to measure OS, descriptive analyses showed a significant OS benefit with lenalidomide maintenance in the first study (median, 9.3 years vs. 7 years; HR = 0.59; 95% CI, 0.44-0.78). Lenalidomide maintenance appeared associated with a small OS benefit in the second study (median, 8.8 years vs. 7.3 years; HR = 0.9; 95% CI, 0.72-1.13), but the difference did not reach statistical significance.
“In newly diagnosed multiple myeloma, auto-HSCT remains a viable option for many patients and often provides a strong response against the disease,” Michael Pehl, president of global hematology and oncology for Celgene, said in the release. “By expanding the approval for Revlimid to include posttransplant maintenance, patients have the potential to maintain those responses and, importantly, delay progression of the disease.”
Adverse events reported in at least 20% of patients in the two maintenance studies included neutropenia (79% in the first study, 61% in the second), thrombocytopenia (72% and 24%), leukopenia (23% and 32%), anemia (21% and 9%), upper respiratory tract infection (27% and 11%), bronchitis (5% and 47%), nasopharyngitis (2% and 35%), cough (10% and 27%), gastroenteritis (0% and 23%), diarrhea (55% and 39%), rash (32% and 8%) and fatigue (23% and 11%).
The most common grade 3 or grade 4 reactions were neutropenia, thrombocytopenia and leukopenia.
Hematologic second primary malignancies occurred in 7.5% of patients who received lenalidomide maintenance and 3.3% of patients who did not receive maintenance.
The FDA in 2006 approved lenalidomide for treatment of patients with myeloma who received at least one prior therapy. The FDA expanded the approval in 2015 to include patients with newly diagnosed myeloma.