Minjuvi
Oncology· 853 cited findings· 2 source documents
Company: Incyte Corporation →
What the regulatory reviews say
Minjuvi is indicated in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) (Grade 1-3a) after at least one line of systemic therapy. The Marketing Authorization Application for Minjuvi was submitted on 30 April 2020, and it received an Orphan Medicinal Product designation on 15 January 2015. A CHMP positive opinion for conditional marketing authorization was issued on 24 June 2021.
Key efficacy findings include an overall response rate of 80.0% and a complete response rate of 60.0%. The median duration of response was 22.8 months. Median progression-free survival ranged from 13.9 months to 39.4 months across different assessments, with a hazard ratio for PFS of 0.40.
Regarding safety, discontinuation due to adverse events was 6.2%. Grade 3 to 4 neutropenia was observed in 50% of participants, and neutropenia (tafasitamab+R2, Grade 3-4) was 46.8%. Febrile neutropenia Grade 3 occurred in 2.4% to 2.5% of participants. The incidence of treatment-emergent adverse events leading to dose modification was 76.6%.
Key figures — cited to the source page
| Overall response rate | 80.0 | Incyte Corporation — Minjuvi EMA EPAR variation assessment r, p.11 |
| Complete response rate | 60.0 | Incyte Corporation — Minjuvi EMA EPAR variation assessment r, p.11 |
| Median duration of response (months) | 22.8 | Incyte Corporation — Minjuvi EMA EPAR variation assessment r, p.11 |
| Hazard ratio for PFS | 0.40 | Incyte Corporation — Minjuvi EMA EPAR variation assessment r, p.11 |
| Discontinuation due to AEs | 6.2 | Incyte Corporation — Minjuvi EMA EPAR variation assessment r, p.96 |
| Grade 3 to 4 neutropenia | 50 | Incyte Corporation — Minjuvi EMA EPAR variation assessment r, p.11 |
| Marketing authorization application submission date | 30 April 2020 | Incyte Corporation — Minjuvi EMA EPAR public assessment repo, p.7 |
| CHMP positive opinion for conditional marketing authorization date | 24 June 2021 | Incyte Corporation — Minjuvi EMA EPAR public assessment repo, p.9 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.