JCA Pulse › Ongoing JCA
Ongoing JCASonrotoclax: EU joint clinical assessment
Treatment of adult patients with relapsed or refractory mantle cell lymphoma
- Regulatory review
- CHMP opinion
- EU authorised
- JCA report published
Overview
- Company
- BeOne Medicines
- Therapy area
- Haematology · Lymphoma
- Indication
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma
- Product type
- Chemical
- EMA validation
- 22 Jan 2026
- JCA assessor
- INAMI-RIZIV, Belgium
- Co-assessor
- TLV, Sweden
- Regulatory status
- Under EMA review. FDA accelerated approval 13 May 2026 (after ≥2 lines incl. BTKi).
- Pivotal evidence
- BGB-11417-201 (phase 1/2, Single-arm)
Scope
The PICO forecast
JCA Pulse forecasts 2–3 PICOs for Sonrotoclax, with 5 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.
Evidence
Fit against the likely scope
Sonrotoclax rests on BGB-11417-201, evidence without a randomised comparator. Pro shows which likely PICOs it can answer, and where the gaps sit.
Comparisons
Trials and indirect comparisons
Pro maps every trial likely in the Sonrotoclax dossier and projects the indirect comparison each comparator will need.
Countries
National translator and outlook
Belgium and Sweden lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets, with 1 national record already in place.
Sources
Last checked 5 November 2026. Compiled from public sources; check them for the latest position. Forecasts are Evidaxia’s independent view, not official assessments.
From Evidaxia
- EU JCA dossiers and PICO scopingSupport from PICO scoping to the dossier
- JCA PICO scoping: process and preparationHow assessors set the scope
- EU JCA timelineEvery upcoming milestone
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