FDA OKs Lenalidomide, Rituximab Combo for Indolent Non-Hodgkin Lymphoma

Officials with the FDA today approved lenalidomide (Revlimid, Celgene) in combination with a rituximab product (R2) for the treatment of adult patients with previously-treated follicular lymphoma or marginal zone lymphoma.

Officials with the FDA today approved lenalidomide (Revlimid, Celgene) in combination with a rituximab product (R2) for the treatment of adult patients with previously-treated follicular lymphoma (FL) or marginal zone lymphoma (MZL), according to a press release.

R2 previously received Priority Review designation from the FDA. With this approval, this is the first combination regimen for patients with these indolent forms of non-Hodgkin lymphoma (NHL) that does not include chemotherapy. Indolent lymphomas, which account for approximately 40% of all NHL cases, are slow-growing forms of the disease, which can often be asymptomatic or have fewer symptoms upon diagnosis. Most patients with indolent forms of NHL will relapse or become refractory to their current treatment, according to Celgene.

“Nearly 15 years following the initial FDA approval, Revlimid continues to demonstrate benefits for new patient populations,” Jay Backstrom, MD, MPH, chief medical officer for Celgene, said in a statement. “Revlimid in combination with rituximab (R2) leads to immune-mediated treatment effects and represents a chemotherapy-free treatment option that can help patients with previously-treated follicular lymphoma and marginal zone lymphoma delay disease progression.”

The approval of R2 is based on data from the phase 3 AUGMENT study evaluating the safety and efficacy of the combination regimen compared with rituximab plus placebo in patients with previously-treated FL and MZL. The study included 358 patients who have received at least 1 prior chemotherapy, immunotherapy, or chemoimmunotherapy regimen. Participants could not be rituximab refractory.

According to the study, patients treated with R2 showed statistically significant improvement in the primary endpoint of progression-free survival (PFS), as evaluated by an independent review committee, compared with rituximab plus placebo. Patients were randomized to rituximab at 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 through 5, plus either 20 mg of lenalidomide daily on days 1 through 21 every 28 days for up to 12 cycles or placebo.

The data showed that the median PFS was 39.4 months for patients treated with R2 versus 14.1 months for those treated with rituximab plus placebo (HR: 0.46; 95% CI, 0.34-0.62; P<0.0001). In the intent-to-treat population, median follow-up time was 28.3 months. The study also demonstrated a numeric trend for improvement in overall survival with R2 versus rituximab plus placebo at early analysis.

Overall, treatment with R2 showed superior efficacy over rituximab monotherapy as measured by PFS, as well as secondary endpoints of overall response rate, complete response, duration of response, and time-to-next antilymphoma treatment.

“Despite additional hematological toxicity, greater efficacy of the R2 regimen (and fewer early progressions) allowed more patients to complete the planned therapy and delayed the need for subsequent treatment,” the study authors concluded.

The most common adverse effects associated with R2 were neutropenia, diarrhea, constipation, cough, fatigue, rash, pyrexia, leukopenia, pruritus, upper respiratory tract infections, abdominal pain, anemia, headache, and thrombocytopenia.

Lenalidomide is also approved for indications in multiple myeloma, mantle cell lymphoma, myelodysplastic syndromes, and autologous hematopoietic stem cell transplantation. It is only available through a restricted distribution program called Revlimid REMS program.


FDA Approves Revlimid (Lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients with Previously Treated Follicular Lymphoma or Marginal Zone Lymphoma [news release]. Celgene. https://ir.celgene.com/press-releases/press-release-details/2019/FDA-Approves-REVLIMID-Lenalidomide-In-Combination-With-Rituximab-For-the-Treatment-of-Adult-Patients-with-Previously-Treated-Follicular-Lymphoma-or-Marginal-Zone-Lymphoma/default.aspx. Accessed May 28, 2019.

Leonard JP, TrnÄ›ný M, Izutsu K, et al. AUGMENT: A phase 3 randomized study of lenalidomide plus rituximab (R2) vs rituximab/placebo in patients with relapsed/refractory indolent non-hodgkin lymphoma. Blood. 2018. Doi: https://doi.org/10.1182/blood-2018-99-110861

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