Biopharmaceutical company Incyte (Nasdaq:INCY) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for adults with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one prior systemic therapy.

A final decision from the European Commission is pending.

If approved, Minjuvi would become the first dual CD19- and CD20-targeted immunotherapy available in Europe for this patient population.

The recommendation is based on results from the Phase 3 inMIND trial in 548 patients, which showed a statistically significant improvement in progression-free survival compared with placebo in combination with lenalidomide and rituximab. Patients receiving Minjuvi achieved a median progression-free survival of 22.4 months versus 13.9 months for the control arm, with consistent findings confirmed by independent review.

Minjuvi was well tolerated with a manageable safety profile. Common adverse reactions included respiratory infections, diarrhea, rash, and fatigue.

Follicular lymphoma accounts for around 30% of non-Hodgkin lymphoma cases, with 2-4 cases per 100,000 people in Western countries. It is considered incurable, with patients frequently relapsing after initial therapy and experiencing a progressively worsening prognosis with each recurrence.

If approved, this would be the second EU indication for Minjuvi, which is already authorised for relapsed or refractory diffuse large B-cell lymphoma.