Tisotumab vedotin (1) – Tivdak®
Cervical cancer, previously treated
Characteristics
| Start date | 01.09.2025 – Marketing authorisation: 28.03.2025 |
|---|---|
| Resolution | 19.02.2026 |
| INN | Tisotumab vedotin |
| Brand name | Tivdak® |
| Pharm. company | Genmab Germany GmbH |
| G-BA Procedure ID | D-1236 |
| ATC code | L01FX23 Other monoclonal antibodies and antibody drug conjugates (L01FX) |
| ICD-10 codes (AIS) | C53.0Malignant neoplasm of endocervix, C53.1Malignant neoplasm of exocervix, C53.8Malignant neoplasm of overlapping sites of cervix uteri, C53.9Malignant neoplasm of cervix uteri, unspecified |
| Alpha-ID codes (AIS) | I102090Malignant neoplasm of the cervical stump, I102158Malignant neoplasm of the cervix uteri, I23846Malignant neoplasm of the ectocervix, I23916Malignant neoplasm of the endocervix |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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Tivdak is used as monotherapy for the treatment of adult female patients with recurrent or metastatic cervical cancer whose disease has progressed during or following systemic therapy. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Erwachsene Patientinnen mit rezidiviertem oder metastasiertem Zervixkarzinom, bei denen eine Krankheitsprogression während oder nach einer platin-basierten Erstlinienchemotherapie aufgetreten ist, die nicht mit einem PD-(L)1-Antikörper vorbehandelt sind und für die eine weitere systemische, antineoplastische Standardtherapie in Frage kommt | |
| b) | Erwachsene Patientinnen mit rezidiviertem oder metastasiertem Zervixkarzinom, bei denen eine Krankheitsprogression während oder nach - einer platin-freien Erstlinien-Chemotherapie ohne einem PD-(L)1-Antikörper, - einer Erstlinien-Kombinationstherapie aus Chemotherapie und einem PD-(L)1-Antikörper, - einer sequenziellen Therapie mit einer platin-haltigen Chemotherapie und einem PD-(L)1-Antikörper aufgetreten ist und für die eine weitere systemische, antineoplastische Standardtherapie in Frage kommt | |
| c) | Erwachsene Patientinnen mit rezidiviertem oder metastasiertem Zervixkarzinom, bei denen eine Krankheitsprogression während oder nach systemischer Vortherapie aufgetreten ist und für die eine weitere systemische, antineoplastische Standardtherapie nicht in Frage kommt |
Studies and Results
- Clinical trials
- The innovaTV 301 trial is an open-label, randomised Phase III trial comparing tisotumab vedotin with chemotherapy selected by the investigator.
a) Adult female patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after first-line platinum-based chemotherapy, who have not been pre-treated with a PD-(L)1 antibody and who are eligible for further standard systemic antineoplastic therapy
- An additional benefit is not proven.
- The pharmaceutical manufacturer did not submit any data in the dossier for patient group a to assess the additional benefit of trastuzumab vedotin compared with the appropriate comparator therapy.
b) Adult female patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after - platinum-free first-line chemotherapy without a PD-(L)1 antibody, – first-line combination therapy comprising chemotherapy and a PD-(L)1 antibody, – sequential therapy with platinum-containing chemotherapy and a PD-(L)1 antibody, and for whom further standard systemic antineoplastic therapy is an option
- The additional benefit is not proven.
- The pharmaceutical manufacturer presents the results for the overall population of the innovaTV 301 study for patient group b.
- However, the data on the overall population are not suitable for assessing the additional benefit for patient group b, as the study mainly included female patients who had not been pre-treated with a PD-(L)1 antibody.
- For patient group b, no data were submitted for the relevant patient population that met the criteria regarding prior treatment and the implementation of the appropriate comparator therapy.
- Consequently, no suitable data are available for comparison with the appropriate comparator therapy.
c) Adult female patients with recurrent or metastatic cervical cancer who have experienced disease progression during or after prior systemic therapy and for whom further standard systemic antineoplastic therapy is not an option
- An additional benefit is not proven.
- In the dossier, the pharmaceutical manufacturer did not provide any data for patient group c to assess the additional benefit of trastuzumab vedotin compared with the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tisotumab vedotin (1) | Tivdak® | Genmab Germany GmbH | Cervical cancer, previously treated | 381–1,452 | 100% additional benefit not proven |
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