WILMINGTON, DE — Incyte (Nasdaq: INCY) said the European Commission has approved Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma, introducing the first CD19- and CD20-dual-targeted, chemotherapy-free immunotherapy regimen for this population in Europe.
The approval applies to patients with Grade 1–3a follicular lymphoma who have received at least one prior line of systemic therapy. It follows a positive opinion issued in November by the European Medicines Agency’s Committee for Medicinal Products for Human Use and represents the second approved indication for Minjuvi in the European Union.
“The EC approval of Minjuvi addresses a critical need, bringing a new, first-of-its-kind, chemotherapy-free option to patients in Europe with relapsed or refractory FL,” said Bill Meury, president and chief executive officer of Incyte. He said treatment options have historically been limited in the second-line setting and that the decision marks a meaningful advance for patients facing repeated relapse.
The regulatory decision was based on results from the Phase 3 inMIND trial, which evaluated Minjuvi in combination with rituximab and lenalidomide versus placebo plus rituximab and lenalidomide. The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival.
Patients receiving the Minjuvi combination achieved a median progression-free survival of 22.4 months by investigator assessment, compared with 13.9 months in the control arm. Independent review results were consistent, with a hazard ratio indicating a marked reduction in the risk of disease progression. The trial also showed fewer exacerbations requiring hospitalization or emergency care, and the therapy was generally well tolerated, with a safety profile comparable to the control regimen.
Follicular lymphoma is the most common slow-growing form of B-cell non-Hodgkin lymphoma and accounts for roughly 30 percent of cases globally. While initial treatment can be effective, the disease is considered incurable, with many patients relapsing and experiencing diminishing outcomes over time. In Western countries, including Europe, relapsed or refractory follicular lymphoma affects an estimated 2 to 4 people per 100,000.
“Relapsed or refractory FL is an incurable, complex and persistent cancer,” said Dr. Stefano Luminari, a professor of oncology at the University of Modena and Reggio Emilia and an investigator in the inMIND study. He said the approval introduces an important innovation that has demonstrated a meaningful reduction in the risk of disease progression, including among patients with high-risk disease.
Minjuvi is a humanized, Fc-modified monoclonal antibody targeting CD19 and is designed to enhance immune-mediated destruction of malignant B cells. Incyte holds exclusive worldwide rights to develop and commercialize the therapy under a licensing agreement with Xencor.
Incyte said Minjuvi has also received regulatory approvals in other indications and regions, with additional global reviews ongoing, further expanding the company’s oncology footprint as it seeks to address unmet needs in hematologic cancers.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.