Answer
The press release tells us that the Phase 3 EPCORE® FL‑1 trial of sub‑cutaneous epcoritamab + rituximab + lenalidomide (R2) versus R2 alone has met both pres‑specified primary endpoints:
| Endpoint | Result | Statistical significance |
|---|---|---|
| Overall response rate (ORR) | Positive (p < 0.0001) | Highly significant |
| Progression‑free survival (PFS) | Hazard ratio = 0.21 | p < 0.0001 (implied) |
When a pivotal Phase 3 trial delivers results of this magnitude, the sponsor (Genmab) will typically move straight to filing a regulatory marketing‑authorisation application with the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The exact filing date has not been announced, but we can outline the realistic timetable based on the standard regulatory pathways and the “fast‑track” options that are likely to be pursued given the strength of the data.
1. United States (FDA)
| Milestone | Approximate Timing |
|---|---|
| Data lock & final statistical analysis – usually within 1–2 months after the data‑cutoff. | Late 2025 (Q4) |
| Preparation of the Biologics License Application (BLA) – compilation of the clinical data package, CMC (chemistry, manufacturing, controls) data, and pre‑clinical information. | Q4 2025 – Q1 2026 |
| Submission of the BLA – Genmab is expected to request Priority Review (or possibly Accelerated Approval if a surrogate endpoint is used) because the trial shows a dramatic PFS benefit (HR 0.21) and a very high ORR. | Q1 2026 |
| FDA review clock – • Standard review: 10 months (average). • Priority review: 6 months. • Accelerated approval (if granted): 6 months plus a post‑marketing confirmatory trial. |
Q2–Q3 2026 (if priority/accelerated) or Q3–Q4 2026 (standard) |
| Potential FDA action (Approval, Complete Response Letter, or request for additional data) | Mid‑2026 |
| Commercial launch in the U.S. – contingent on a positive decision. | Late 2026 (if approved) |
Bottom‑line: Assuming Genmab files the BLA in Q1 2026 and secures Priority Review, the earliest realistic FDA approval would be mid‑2026 (≈ 6 months after filing). If the agency opts for a standard review, the window stretches to late 2026.
2. Europe (EMA)
| Milestone | Approximate Timing |
|---|---|
| Data lock & final analysis – same as U.S. (late 2025). | Late 2025 |
| Preparation of the Marketing Authorisation Application (MAA) – includes the same clinical dossier plus EU‑specific CMC and pharmacovigilance plan. | Q4 2025 – Q1 2026 |
| Submission of the MAA – Genmab is likely to request Accelerated Assessment (a 150‑day review instead of the standard 210‑day) because the data are compelling and there is an unmet medical need in relapsed/refractory follicular lymphoma. | Q1 2026 |
| EMA review clock – • Standard centralized procedure: ~12 months. • Accelerated assessment: 150 days (≈ 5 months) for the scientific assessment, plus a validation phase (up to 3 months) before the final decision. |
Q2–Q3 2026 (accelerated) or Q3–Q4 2026 (standard) |
| Potential EMA action (Approval, CHMP recommendation, or request for additional data) | Mid‑2026 |
| Commercial launch in the EU – after the European Commission issues the final decision. | Late 2026 (if approved) |
Bottom‑line: With an Accelerated Assessment request, the EMA could issue a positive marketing authorisation by the second half of 2026 (≈ 5–8 months after filing). A standard review would push the decision to late 2026.
3. Key Factors That Could Shorten or Extend These Timelines
| Factor | Potential impact |
|---|---|
| Regulatory designations (e.g., FDA’s “Breakthrough Therapy” or “Fast Track”; EMA’s “PRIME” or “Accelerated Assessment”) – if granted, the review clock can be halved. | |
| Manufacturing readiness – Genmab must have a validated, GMP‑compliant sub‑cutaneous epcoritamab production line. Any pending scale‑up or facility inspections could add 1–2 months. | |
| Safety signals – The press release does not mention any new safety concerns. Absence of safety flags usually speeds up the review. | |
| Post‑marketing commitments – If the FDA opts for Accelerated Approval, a confirmatory Phase 4 study will be required, but the initial approval can still be granted within the 6‑month priority window. | |
| Concurrent regulatory filings – Genmab may bundle the FL indication with other epcoritamab programmes (e.g., DLBCL) to leverage a “sameness” argument, which could either streamline or complicate the dossier. |
4. Practical Take‑away for Stakeholders
| Audience | What to expect |
|---|---|
| Investors | Assuming a Q1 2026 filing, the first half of 2026 is the most probable window for a U.S. FDA decision and a mid‑2026 EMA decision. This aligns with a potential commercial launch in 2026‑2027. |
| Clinicians & Patients | If approved, epcoritamab + R2 could become a new standard of care for relapsed/refractory follicular lymphoma within 12–18 months of the data release, offering a sub‑cutaneous, bispecific antibody option with a markedly improved PFS. |
| Regulatory teams | Prepare priority/accelerated review dossiers now, finalize CMC data, and schedule pre‑submission meetings (e.g., FDA’s Type B meeting, EMA’s Scientific Advice) in Q4 2025 to ensure a smooth filing in early 2026. |
5. Bottom‑line Summary
| Region | Likely regulatory pathway | Earliest realistic approval date |
|---|---|---|
| United States (FDA) | Priority Review (or Accelerated Approval) based on very strong Phase 3 data | ~ June 2026 (≈ 6 months after filing) |
| Europe (EMA) | Accelerated Assessment (centralized procedure) | ~ September 2026 (≈ 5–8 months after filing) |
If Genmab follows the typical timeline of filing in Q1 2026, stakeholders can anticipate first regulatory decisions in the middle of 2026 and, assuming a positive outcome, market entry in the latter half of 2026 (U.S.) and late 2026 (EU).