Tafasitamab-cxix is approved by the USFDA for relapsed or refractory follicular lymphoma

On June 18, 2025, the Food and Drug Administration sanctioned tafasitamab-cxix (Monjuvi, Incyte Corporation) in conjunction with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL).

Safety and Efficacy

The efficacy was assessed in inMIND, a double-blind, placebo-controlled trial (NCT04680052) that randomized 548 patients with relapsed or refractory follicular lymphoma to receive tafasitamab-cxix or placebo in conjunction with lenalidomide and rituximab. Patients had undergone a median of 1 previous line of systemic therapy; 25% and 20% had received 2 and 3 or more prior lines, respectively.

The primary effectiveness outcome measure was investigator-evaluated progression-free survival (PFS). Following a median follow-up of 14.1 months, progression-free survival (PFS) was statistically substantially prolonged in the tafasitamab-cxix group (hazard ratio 0.43 [95% CI: 0.32, 0.58]; p-value <0.0001). The projected median progression-free survival (PFS) was 22.4 months (95% CI: 19.2, not evaluable) for the tafasitamab-cxix group and 13.9 months (95% CI: 11.5, 16.4) for the control group.

Severe adverse events were observed in 33% of patients in the tafasitamab-cxix group, with serious infections affecting 24%. The prescribing information for tafasitamab-cxix contains warnings and precautions about infusion-related reactions, myelosuppression, and infections.

Suggested Dosage

The advised dosage of tafasitamab-cxix is 12 mg/kg administered as an intravenous infusion for a maximum of 12 cycles in conjunction with lenalidomide and rituximab. Tafasitamab-cxix is not advised or recommended for patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

Nishant Mittal (PhD)

+ postsBio ⮌

Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. His career is marked by significant contributions to stem cell biology, developmental biology, and innovative research techniques.

Research Highlights

Dr. Mittal's research has focused on several key areas:

1) Cardiovascular Development and Regeneration: He studied coronary vessel development and regeneration using zebrafish models1.

2) Cancer Biology: At Dartmouth College, he developed zebrafish models for studying tumor heterogeneity and clonal evolution in pancreatic cancer.
3) Developmental Biology: His doctoral work at Keio University involved identifying and characterizing medaka fish mutants with cardiovascular defects.

4) Stem Cell Research: He investigated the effects of folic acid on mouse embryonic stem cells and worked on cryopreservation techniques for hematopoietic stem cells.

Publications and Presentations

Dr. Mittal has authored several peer-reviewed publications in reputable journals such as Scientific Reports, Cardiovascular Research, and Disease Models & Mechanisms1. He has also presented his research at numerous international conferences, including the Stanford-Weill Cornell Cardiovascular Research Symposium and the Weinstein Cardiovascular Development Conference.

In summary, Dr. Nishant Mittal is a dedicated and accomplished researcher with a strong track record in cardiovascular and cancer biology, demonstrating expertise in various model systems and a commitment to advancing scientific knowledge through innovative research approaches.

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• August 21st, 2025