Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
Lu-177 n.c.a. + FAPIInvestigational Tumour-Stroma Theranostic
No-carrier-added Lutetium-177 (produced by SHINE Medical, supplied across India by Saxsons) paired with FAPI-46 (or FAPI-04) for fibroblast-activation-protein-targeted radionuclide therapy. An emerging tumour-stroma theranostic with peer-reviewed pilot data in pancreatic adenocarcinoma, soft-tissue sarcoma and FAP-positive solid tumours. Supplied for investigational and hospital-ethics-approved use only.
Key Features
- Investigational use only — ¹⁷⁷Lu-FAPI is not yet a regulator-approved standard-of-care indication; supplied for hospital-ethics-committee-approved or clinical-trial protocols
- No-carrier-added Lu-177 starting material — same upstream cGMP / ICH-Q7 dossier as PRRT and PSMA programmes
- Compatible with FAPI-46 (clinically dominant) and FAPI-04 (early-generation) peptide chemistries
- Targets fibroblast activation protein (FAP) — overexpressed on cancer-associated fibroblasts in the tumour stroma across pancreatic adenocarcinoma, soft-tissue sarcoma, breast / colorectal subsets and other epithelial cancers
- Theranostic pairing with Ga-68 FAPI or F-18 FAPI PET/CT for FAP-expression imaging and per-cycle response
All Features
- Investigational use only — ¹⁷⁷Lu-FAPI is not yet a regulator-approved standard-of-care indication; supplied for hospital-ethics-committee-approved or clinical-trial protocols
- No-carrier-added Lu-177 starting material — same upstream cGMP / ICH-Q7 dossier as PRRT and PSMA programmes
- Compatible with FAPI-46 (clinically dominant) and FAPI-04 (early-generation) peptide chemistries
- Targets fibroblast activation protein (FAP) — overexpressed on cancer-associated fibroblasts in the tumour stroma across pancreatic adenocarcinoma, soft-tissue sarcoma, breast / colorectal subsets and other epithelial cancers
- Theranostic pairing with Ga-68 FAPI or F-18 FAPI PET/CT for FAP-expression imaging and per-cycle response
- Pilot peer-reviewed data from the Heidelberg group (Kratochwil, Giesel) and multi-centre dosimetry collaborations
- Dose-escalation and dose-limiting toxicity studies ongoing — no single standard cycle yet; per-protocol activity per cycle
- Saxsons supplies cold-chain delivery, AERB import documentation and FAPI peptide kit pairing for investigator-initiated trials
- Patient eligibility, informed consent and CDSCO investigational-use coverage required per study protocol
- Dosimetry consultation available — Lu-177 208 keV imaging gamma for post-therapy SPECT/CT
- Same supply chain as ¹⁷⁷Lu-DOTATATE and ¹⁷⁷Lu-PSMA-617 — one Saxsons import line covers all three
- Investigator support — documentation aligned with hospital ethics committee, AERB and CDSCO Form CT-04 / IND requirements
Technical Specifications
| Radionuclide | Lutetium-177 (¹⁷⁷Lu) — n.c.a. starting material |
| Targeting ligand | FAPI-46 (dominant clinical chemistry) or FAPI-04 (early generation) |
| Molecular target | Fibroblast activation protein α (FAPα) on cancer-associated fibroblasts |
| Tumour types under study | Pancreatic adenocarcinoma, soft-tissue sarcoma, breast / colorectal subsets, advanced epithelial cancers |
| Activity per cycle | Per-protocol; published dose-escalation range ~3.7–7.4 GBq per cycle |
| Cycle interval | Per-protocol; typically 6–8 weeks |
| Half-life | 6.647 days |
| Imaging gamma | 208 keV (11 %) — quantitative SPECT/CT post-therapy |
| Theranostic pairing | Ga-68 FAPI or F-18 FAPI PET/CT for FAP imaging |
| Regulatory framework | Hospital ethics committee approval; CDSCO investigational-use coverage; AERB import licence (handled by Saxsons) |
| Quality release | Per-batch Certificate of Analysis on the Lu-177 starting material; per-protocol QC on the labelled product (radiochemical purity, sterility, endotoxin) |
| Supply status | Investigational — available to AERB-licensed centres with documented hospital-ethics-committee or trial coverage |
Applications
Tumour-stroma theranostics — investigational, evidence-building, ethics-anchored
Pancreatic adenocarcinoma
Pancreatic ductal adenocarcinoma carries dense FAP-positive stroma. Pilot ¹⁷⁷Lu-FAPI cohorts (Heidelberg, multi-centre) report symptomatic and biochemical responses in advanced pancreatic cancer where no curative option exists. Use is investigational and hospital-ethics-committee-approved.
Soft-tissue sarcoma
Sarcoma subtypes (e.g. liposarcoma, leiomyosarcoma) display variable but often high FAP expression on Ga-68 FAPI PET. ¹⁷⁷Lu-FAPI dose-escalation studies position the therapy as a stroma-directed option after standard chemotherapy lines exhaust.
FAP-positive epithelial cancers
Breast, colorectal, gastric and head-and-neck cancers can present FAP-positive subsets on PET imaging. Ga-68 FAPI PET screens candidates for ¹⁷⁷Lu-FAPI therapy in academic and trial protocols.
Theranostic-paired imaging
Ga-68 FAPI / F-18 FAPI PET/CT for FAP expression and lesion-by-lesion selection; post-therapy ¹⁷⁷Lu SPECT/CT for delivered-dose verification. One molecular target across imaging and therapy.
Dosimetry-led dose-escalation
Multi-centre dosimetry collaborations characterise tumour and organ-at-risk dose per GBq across FAPI peptide variants. ¹⁷⁷Lu-FAPI is one of the most actively dose-escalating theranostic protocols.
Investigator-initiated programmes
Indian academic centres (AIIMS, Tata Memorial, BARC-collaborating centres) may run ¹⁷⁷Lu-FAPI under hospital ethics committee + CDSCO investigational coverage. Saxsons supports the radionuclide supply and the AERB licensing leg.
Why Lu-177 n.c.a. + FAPI?
¹⁷⁷Lu-FAPI is currently used in clinical trials, investigator-initiated protocols, and ethics-committee-approved compassionate-use cases. There is no FDA / EMA / CDSCO-approved standard-of-care indication today. Treat ¹⁷⁷Lu-FAPI supply as a research-and-trial line, not a routine clinical line — the patient-consent and audit trail expectations match.
Pancreatic adenocarcinoma, sarcoma and FAP-positive epithelial cancers express little SSTR2 and little PSMA — DOTATATE and PSMA-617 do not see them. FAP-targeted ¹⁷⁷Lu-FAPI extends theranostic reach into tumour types currently unreachable by the established radionuclide therapies, which is the clinical rationale driving the dose-escalation studies.
A centre already running PRRT / PSMA on n.c.a. Lu-177 can layer FAPI on the same supply chain — one Saxsons import line, one cold-chain calibration schedule, one regulatory dossier on the radionuclide. The differentiation is downstream: ethics committee, peptide kit, protocol.
Catalogs & Resources
SHINE product page for the upstream Lu-177 n.c.a. starting material. Contact Saxsons for AERB import documentation, FAPI peptide kit pairing and investigator-initiated-protocol support.
Lu-177 + FAPI
More for this product
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Build the supply chain for your ¹⁷⁷Lu-FAPI investigator-initiated programme
Contact Saxsons Group for n.c.a. Lu-177 + FAPI supply agreements, AERB import documentation, ethics-committee paperwork support and India cold-chain scheduling for investigational use.