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
Each card opens a focused post for a specific specialty — peer-reviewed evidence and clinical workflow, written for the persona you select.
FAQ
Lu-177 FAPI theranostic — questions we hear from Indian theranostic teams
What tumour biology FAPI targets, how it differs from PSMA and DOTATATE, which patient population is appropriate, and the Indian regulatory framing for FAPI theranostic administration.
Q.What tumour biology does Lu-177 FAPI actually target?
FAPI (fibroblast activation protein inhibitor) targets fibroblast activation protein (FAP), a serine protease expressed on cancer-associated fibroblasts in the tumour stroma. FAP is present in high density in many solid tumours — pancreatic, gastric, cholangiocarcinoma, sarcoma, breast, ovarian — often at densities greater than the tumour cells themselves. Lu-177-FAPI-46 or Lu-177-FAPI-04 delivers therapeutic beta radiation to the FAP-expressing stromal compartment, hitting the tumour microenvironment rather than the tumour cell alone.
Q.How is this different from Lu-177 PSMA and Lu-177 DOTATATE?
PSMA targets prostate-specific membrane antigen (upregulated on prostate cancer cells) and DOTATATE targets somatostatin receptor 2 (upregulated on neuroendocrine tumours). Both target the tumour cell directly, and both are limited to specific tumour types that express the target. FAPI targets the tumour stroma, which is present across many solid-tumour types — so Lu-177 FAPI opens theranostic access to indications (pancreatic, sarcoma, cholangiocarcinoma) that PSMA / DOTATATE do not cover.
Q.Which patient population is Lu-177 FAPI clinically appropriate for?
Patients with metastatic or unresectable FAP-positive solid tumours who have exhausted standard-of-care systemic therapy, and who show positive Ga-68 FAPI PET/CT uptake in the target lesions (the theranostic pair — Ga-68 FAPI selects the patient, Lu-177 FAPI treats). Typical indications in current clinical use: pancreatic ductal adenocarcinoma, sarcoma subtypes, cholangiocarcinoma, gastric, ovarian and selected breast primaries. Indication is centre-specific and protocol-driven.
Q.What Indian regulatory framework governs Lu-177 FAPI therapy?
The Lu-177 radionuclide falls under the AERB Safety Code for Nuclear Medicine Facility for theranostic administration; the FAPI targeting-ligand chemistry is a hospital-radiopharmacy compounded product under the site's IEC-approved protocol. Most Indian centres running Lu-177 FAPI do so under an institutional ethics committee-approved investigator-initiated clinical protocol rather than as approved standard-of-care.
Q.How is Lu-177 FAPI supplied and supported in India?
Distributed across India by Saxsons Group. Supply covers scheduled-date Lu-177 delivery to the labelling radiopharmacy, FAPI-46 / FAPI-04 precursor sourcing, receiving documentation for AERB, per-consignment activity certification and clinical-support coordination with the centre's theranostic programme.
Lu-177 n.c.a. + FAPI supplier in India — Saxsons Group
Saxsons Group has supplied nuclear medicine equipment to over 1,000 Indian hospitals since 1988. Every consignment of Lu-177 n.c.a. + FAPI ships with cold-chain logistics, AERB import documentation, CDSCO registration references and a Certificate of Analysis delivered before dispatch — the paperwork your radiation-safety and procurement teams need, pre-assembled.
- Nationwide delivery footprint — every metro and tier-2 city in India, scheduled to your treatment / procedure calendar.
- AERB & CDSCO documentation — import licence, radiation-safety paperwork and RSO briefing pre-assembled for the audit file.
- 40+ years in Indian oncology — long-standing supply relationships with AIIMS, Tata Memorial, and hundreds of tertiary-care centres.
- Single point of accountability — one purchase order, one delivery contact, one after-sales team across the whole product family.
Also supplied by Saxsons Group across India
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.