Polivy Approval Age and Trial Eligibility
Polivy (polatuzumab vedotin-piiq), approved by the FDA in 2019 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in combination with bendamustine and rituximab, targets adults 18 years and older. Its label specifies use in patients who have received at least two prior therapies, with no pediatric indication.[1]
Minimum Age in Key Clinical Trials
The pivotal phase 2 GO29365 trial (NCT02257567), which supported approval, enrolled patients aged 18 to 80 years. No participants under 18 were included, reflecting the adult focus on aggressive lymphomas rare in children.[2][3]
Ongoing or completed trials follow suit:
- Phase 3 POLARIX (NCT03274492) for first-line DLBCL: 18-80 years.[4]
- Phase 2/3 GO29365 extensions and phase 1b/2 studies: Minimum 18 years, often up to 80.[5]
Why No Younger Ages in Trials?
DLBCL incidence peaks in adults over 60; pediatric cases (often ALK-positive ALCL or other subtypes) use different regimens like CHOP or pediatric protocols. Polivy's antibody-drug conjugate mechanism targets CD79b, expressed in mature B-cells, limiting relevance for younger patients.[6]
Pediatric Trials or Exceptions?
No Polivy trials include patients under 18. ClinicalTrials.gov lists zero studies with a minimum age below 18. Roche/Genentech trials explicitly exclude pediatrics due to pharmacokinetics, safety data gaps, and low disease prevalence in kids.[7]
Access for Younger Patients
Patients under 18 with DLBCL rely on off-label chemo-immunotherapy (e.g., R-CHOP) or trials for pediatric lymphomas. No compassionate use or expanded access for Polivy in minors is documented.[8]
Sources:
[1] FDA Polivy Label: https://www.accessdata.fda.gov/drugsatfdadocs/label/2019/761121s000lbl.pdf
[2] GO29365 Trial (PubMed): https://pubmed.ncbi.nlm.nih.gov/32366245/
[3] ClinicalTrials.gov GO29365: https://clinicaltrials.gov/study/NCT02257567
[4] ClinicalTrials.gov POLARIX: https://clinicaltrials.gov/study/NCT03274492
[5] Roche Pipeline: https://www.roche.com/researchand_development/pipeline
[6] SEER Cancer Stats: https://seer.cancer.gov/statfacts/html/dlbc.html
[7] ClinicalTrials.gov Search 'Polivy' (age filter): https://clinicaltrials.gov/search?term=polivy
[8] Genentech Access: https://www.genentech-access.com/