Tafasitamab-Based Regimen Nets Approval in Brazil for R/R Follicular Lymphoma

Tafasitamab (Minjuvi) in combination with lenalidomide (Remlivid) and rituximab (Rituxan) has been approved by ANVISA in Brazil for the treatment of adult patients with relapsed or refractory follicular lymphoma.¹

The decision was supported by efficacy data from the phase 3 inMIND study (NCT04680052), which evaluated the combination in patients with relapsed or refractory follicular lymphoma who had received at least one line of prior systemic therapy that included an anti-CD20 antibody.^1,2

Data from the trial showed that patients in the combination arm (n = 273) achieved a median progression-free survival (mPFS) of of 22.37 months (95% CI: 19.22-Not-Evaluable [NE]) vs 13.93 months (95% CI: 11.53-16.39) for patients who received a placebo in combination with lenalidomide and rituximab (n = 275), resulting in a hazard ratio of 0.434 (95% CI: 0.324-0.580; P < 0.0001). In addition to a 57% reduction in the risk of disease progression or death, the combination also demonstrated a more favorable safety profile in comparison to the placebo. The most common any-grade adverse effects (AEs) that occurred in 20% or more of patients in the combination arm were respiratory tract infections, diarrhea, and rashes.

“ANVISA’s approval of the new indication for tafasitamab in combination with rituximab and lenalidomide represents an important step in expanding treatment options for patients with relapsed or refractory follicular lymphoma. As a chemotherapy-free option with a favorable risk-benefit profile, this approval broadens therapeutic alternatives for patients across Brazil,” said Jorge Vaz Pinto Neto, MD, in a news release.

Pinto Neto is a hematologist at Universidade Estadual de Campinas and coordinator of the Bone Marrow Transplant Unity at CETTRO Cancer Center/Oncoclinicas, both in Brazil.

How was the inMIND study evaluating tafasitamab plus rituximab/lenalidomide in R/R follicular lymphoma designed?

The randomized, double-blind trial enrolled patients who were 18 years of age with grade 1 to 3a relapsed or refractory follicular lymphoma that was either nodal, splenic, or extranodal marginal zone.

PFS per investigator assessment in the intention-to-treat population of patients was the trial’s primary end point. PFS, complete response (CR) rate, overall survival (OS), served as secondary end points for the trial.

Patients in the trial were administered intravenous (IV) tafasitamab at 12 mg/kg on days 1, 8, 15, and 22 of the first 3 cycles. Patients then received the same dose of tafasitamab on days 1 and 15 for the rest of the treatment cycles. Patients also received 20 mg of oral lenalidomide once per day on the first 21 days of each cycle. IV rituximab was given to patients in 375 mg/m² fusions on days 1, 8, and 15 of the first cycle of treatment and then on day 1 of the next 4 cycles. Cycles of treatment were 28 days long and patients were able to receive up to 12 cycles of treatment.

What are the additional data for tafasitamab plus rituximab/lenalidomide?

Other any-grade AEs that occurred in at least 20% of patients were fatigue, constipation, cough, and musculoskeletal pain. Grade 3 or 4 AEs that were experienced in at least 20% of patients were decreased neutrophil count and decreased lymphocytes.

Before the ANVISA approval, tafasitamab plus lenalidomide and rituximab was approved for relapsed or refractory follicular lymphoma by the FDA in June 2025. The combination was also approved for the treatment of relapsed or refractory follicular lymphoma by Japan’s Ministry of Health, Labour and Welfare in January 2026. Finally, the combination was approved for the same patient population by Europe’s CHMP in December 2025.

“This approval of MINJUVI® delivers on our promise to bring high quality cancer care to Latin America and provides physicians and patients a new option in the treatment of relapsed or refractory lymphoma,” said Samira Sakhia, the president and CEO of Knight Therapeutics said in a news release. “The rapid review and approval under Project Orbis reflect Knight’s strong regulatory capabilities and focused execution for the benefit of Knight and our partners.”

References

1. Knight therapeutics announces approval of additional indication for MINJUVI® (tafasitamab) in Brazil. News Release. GlobeNewswire. March 17, 2026. Accessed March 23, 2026. https://www.globenewswire.com/news-release/2026/03/17/3257037/0/en/Knight-Therapeutics-Announces-Approval-of-Additional-Indication-for-MINJUVI-tafasitamab-in-Brazil.html_gl=1*1144xt1*_up*MQ..*_ga*MzEzMjE5NDk5LjE3NzM3NTYxMTg.*_ga_B6167QB2TF*czE3NzM3NTYxMTgkbzEkZzAkdDE3NzM3NTYxMTgkajYwJGwwJGgw*_ga_ERWPGTJ5X8*czE3NzM3NTYxMTgkbzEkZzAkdDE3NzM3NTYxMTgkajYwJGwwJGgw
2. Sehn LH, Hübel K, Luminari S, et al. Tafasitamab, lenalidomide, and rituximab in relapsed or refractory follicular lymphoma (inMIND): a global, phase 3, randomised controlled trial. Lancet. 2026;407(10524):133-146. doi:10.1016/S0140-6736(25)01778-7