Saxsons Group

NM Physician's Notes · ¹⁷⁷Lu-FAPI

Four dossiers stand between a FAPI idea and a treated patient.

Running ¹⁷⁷Lu-FAPI in an Indian centre is not a clinical decision alone — it is a four-body regulatory and ethics undertaking. Hospital ethics committee approves the protocol and patient consent. CDSCO covers the investigational drug-use leg. AERB covers the radiation and import leg. Saxsons supplies the radionuclide leg. This post lists what each dossier contains.

The four dossiers

What each body expects to see

Hospital Ethics Committee

  • Investigator-initiated protocol (IIP) document — rationale, patient selection, dosing, endpoints, safety monitoring
  • Patient information sheet and informed consent (English + regional language)
  • Investigator CV (FRCR / FRSM / DM Nuclear Medicine credentials)
  • Radiation safety officer sign-off
  • Pre-existing Ga-68 / F-18 FAPI PET capability documented
  • Post-therapy SPECT/CT and dosimetry workflow documented

CDSCO (drug regulator)

  • Form CT-04 — clinical trial application if running as a registered trial
  • Or institutional ethics committee approval letter for compassionate / off-protocol use
  • Investigator brochure on the FAPI peptide
  • Pharmacopoeial reference for Lu-177 starting material
  • Adverse event reporting plan (SAE notification to CDSCO within timelines)

AERB (radiation regulator)

  • Lu-177 import licence (Saxsons supplies this)
  • Atomic Energy Regulatory Board theranostic-use approval for the facility
  • Radiation Safety Officer (RSO) certification, current licence
  • Decay-store and waste-disposal SOP for Lu-177 (≈6.65 d primary half-life)
  • Patient release criteria post-Lu-177 administration (dose-rate at 1 m, family-contact guidance)

Saxsons (supply leg, SHINE-sourced)

  • n.c.a. Lu-177 supply agreement — calibration date, activity, vial geometry — production from SHINE Medical (USA)
  • SHINE FDA Drug Master File reference for the upstream radionuclide dossier
  • Cold-chain delivery schedule timed to peptide labelling day
  • Certificate of Analysis with each consignment
  • AERB import paperwork on each consignment
  • Optional dosimetry consultation for protocol design

Practical sequencing note

The hospital ethics committee and CDSCO dossiers move on hospital-administrative timelines (typically 2–4 months from submission). The AERB import licence is faster (4–6 weeks) but depends on the centre's existing radiotherapeutic licence already covering Lu-177. The Saxsons supply leg locks once ethics + CDSCO + AERB are in hand — calibration date is chosen once the first treatable patient is consented and PSMA-imaging-confirmed (analogous workflow expected for FAPI). Don't sequence supply ahead of regulatory; the Lu-177 decays at ~6.65 d half-life and a missed treatment window means a replaced consignment.