The Food and Drug Administration has approved the use of lenalidomide (Revlimid) for maintenance therapy following autologous hematopoietic stem cell transplant in patients with multiple myeloma.
The expanded indication, announced Feb. 22, makes the immunomodulatory agent the first and only approved treatment for post autologous hematopoietic stem cell transplant (auto-HSCT) maintenance. It was initially approved in 2006 for use in combination with dexamethasone in patients with multiple myeloma who have received at least one prior therapy, and that indication was expanded in 2015 to include those with newly diagnosed multiple myeloma.
According to Celgene, the maker of Revlimid, the latest approval was based on data showing that lenalidomide maintenance therapy delays disease progression following auto-HSCT. Updated phase III randomized controlled trial data from two studies including more than 1,000 patients demonstrated median progression-free survival (PFS) advantages with lenalidomide maintenance vs. no maintenance. In one study – the U.S.-based CALGB 1001014 – median PFS was 5.7 vs. 1.9 years for a difference of 3.8 years (hazard ratio, 0.38). In the second study – the European IFM 2005-02 – median PFS was 3.9 vs. 2 years, for a difference of 1.9 years (HR, 0.53).
In both studies lenalidomide was given as a 10-mg daily oral dose (increased to 15 mg daily after 3 months if tolerated) until disease progression or unacceptable toxicity after auto-HSCT.
Lenalidomide, a derivative of thalidomide, can cause fetal harm and is contraindicated in women who are pregnant. It is available only through a restricted distribution program.
The most frequently reported adverse reactions in the two studies were neutropenia, thrombocytopenia, leukopenia, anemia, upper respiratory tract infection, bronchitis, nasopharyngitis, cough, gastroenteritis, diarrhea, rash, fatigue, muscle spasm, and pyrexia. The most frequently reported grade 3 or 4 reactions occurring in more than 20% of patients in the lenalidomide arms included neutropenia, thrombocytopenia, and leukopenia.
“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, of the Roswell Park Cancer Institute in Buffalo, N.Y., said in a Celgene press statement. “Lenalidomide maintenance therapy ... can be considered a standard of care for these patients.”