Retifanlimab
Deterministische Ansicht der Quelle YAML Entität. Klinische Autorität bleibt mit den zitierten Quell-IDs und Rezensenten Sign-off Zustand.
| ID | DRUG-RETIFANLIMAB |
|---|---|
| Art | Arzneimittel |
| Aliase | ZynyzРетифанлімаб |
| Status | reviewed 2026-04-29 | pending_clinical_signoff |
| Erkrankungen | DIS-ANAL-SCC |
| Quellen | SRC-CIVIC |
Drug Facts
| Klasse | Anti-PD-1 humanisierter IgG4κ monoklonaler Antikörper (Immun-Checkpoint-Inhibitor) |
|---|---|
| Verfahren | Humanized IgG4 monoclonal antibody (S228P-stabilized hinge to prevent Fab-arm exchange) that binds programmed death-1 (PD-1) on T-cells and blocks engagement with PD-L1/PD-L2, restoring anti-tumor T-cell effector function. Pivotal POD1UM-202 Phase II in 94 patients with locally advanced or metastatic anal squamous cell carcinoma (SCC) progressing on or intolerant to platinum chemotherapy: ORR 14% (CR 1%, PR 13%), mDOR 9.5 months, supporting FDA accelerated approval Mar 2023 — first PD-1 inhibitor approved for 2L anal SCC. Also under investigation in 1L Merkel cell carcinoma (POD1UM-201) and 1L NSCLC combinations. |
| Typische Dosierung | 500 mg IV über 30 Minuten einmal alle 4 Wochen (Q4W) bis zum Krankheitsverlauf, inakzeptable Toxizität, oder bis zu 24 Monate. Dauerhaft absetzen für Grad 4 immunvermittelte AE, rezidivierende Grad 3 immun AE trotz Kortikosteroiden, oder Grad ≥3 Myokardititis / Enzephalitis / Stevens-Johnson-Syndrom. |
| Ukraine registriert | Falsch |
| NSZU erstattet | Falsch |
| Ukraine zuletzt überprüft | 2026-04-29 |
Anmerkungen
FDA accelerated approval (Mar 2023, Zynyz) for metastatic or recurrent locally advanced anal SCC progressing on or intolerant to platinum-based chemotherapy — first PD-1 inhibitor approved in this indication. EMA approval Aug 2023. POD1UM-303 (1L anal SCC, retifanlimab + carboplatin/paclitaxel vs carboplatin/paclitaxel placebo) reported positive PFS in 2024, supporting label expansion. Retifanlimab carries the standard PD-1 irAE spectrum (pneumonitis, colitis, endocrinopathies, hepatitis, nephritis, myocarditis); baseline TSH/T4, cortisol, and full immune-mediated AE counseling are required. Missing source IDs to flag for follow-up: SRC-POD1UM-202, SRC-POD1UM-303, SRC-FDA-ZYNYZ not yet authored — citation thin (SRC-CIVIC only). NCCN does not yet publish a stand-alone Anal Carcinoma guideline source in this KB catalog; an authoritative guideline source requires source-intake review.
Verwendet von
Therapieschema
REG-RETIFANLIMAB-CARBO-PACLI-ANAL-1L- Retifanlimab + carboplatin + paclitaxel (fortgeschrittener Anal SCC 1L, POD1UM-303)