Retifanlimab
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-RETIFANLIMAB |
|---|---|
| Тип | Препарат |
| Синоніми | ZynyzРетифанлімаб |
| Статус | переглянуто 2026-04-29 | очікує клінічного підпису |
| Хвороби | DIS-ANAL-SCC |
| Джерела | SRC-CIVIC |
Дані про препарат
| Клас | Anti-PD-1 humanized IgG4κ monoclonal antibody (immune checkpoint inhibitor) |
|---|---|
| Механізм дії | 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. |
| Типове дозування | 500 mg IV over 30 minutes once every 4 weeks (Q4W) until disease progression, unacceptable toxicity, or up to 24 months. Permanently discontinue for grade 4 immune-mediated AE, recurrent grade 3 immune AE despite corticosteroids, or grade ≥3 myocarditis / encephalitis / Stevens-Johnson syndrome. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| Остання перевірка для України | 2026-04-29 |
Нотатки
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 (would be SRC-NCCN-ANAL-202X); flag for source-ingestion workstream.
Де використовується
Regimens
REG-RETIFANLIMAB-CARBO-PACLI-ANAL-1L- Retifanlimab + carboplatin + paclitaxel (advanced anal SCC 1L, POD1UM-303)