Pembrolizumab (30) – Keytruda®
Melanoma, ≥ 12 to < 18 years
Characteristics
| Start date | 01.08.2022 – Marketing authorisation: 22.06.2022 |
|---|---|
| Resolution | 19.01.2023 |
| INN | Pembrolizumab |
| Brand name | Keytruda® |
| Pharm. company | MSD Sharp & Dohme GmbH |
| G-BA Procedure ID | D-847 |
| ATC code | L01FF02 PD-1/PDL-1 inhibitors (L01FF) |
| ICD-10 codes (AIS) | C43.0Malignant melanoma of lip, C43.1Malignant melanoma of eyelid, including canthus, C43.2Malignant melanoma of ear and external auricular canal, C43.3Malignant melanoma of other and unspecified parts of face, C43.4Malignant melanoma of scalp and neck, C43.5Malignant melanoma of trunk, C43.6Malignant melanoma of upper limb, including shoulder, C43.7Malignant melanoma of lower limb, including hip, C43.8Malignant melanoma of overlapping sites of skin, C43.9Malignant melanoma of unspecified site of skin |
| Alpha-ID codes (AIS) | I111156Malignant melanoma of the hairy scalp, I111633Malignant melanoma of the ear and external auditory canal, I18282Malignant melanoma, I18791Malignant melanoma of the eyelid, I3412Malignant melanoma of the lip, I3416Malignant melanoma of the face, I96395Malignant melanoma of the trunk n.c, I96441Malignant melanoma of the upper extremity n.c, I96442Malignant melanoma of the lower extremity n.c |
| DDD | 9.5 mg P |
| Therapeutic area | Oncological diseases Melanoma (MA) |
| Reason for procedure | New therapeutic indication |
| Specialty | Bundling |
| Therapeutic indication of the resolution |
|---|
|
Keytruda is indicated as monotherapy for the treatment of advanced (non-resectable or metastatic) melanoma in children and adolescents aged 12 years and older |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children and adolescents aged 12 years and older with advanced (non-resectable or metastatic) melanoma. | Treatment according to physician's choice |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (KEYNOTE 051) |
|---|---|
|
Study design
(best subpopulation) |
Single-arm + no comparison |
|
Meta analysis
(best subpopulation) |
no |
- Clinical trials
- The KEYNOTE 051 trial is an open-label, ongoing, non-randomised, multicentre, single-arm Phase I/II trial enrolling children and adolescents aged ≥ 6 months to < 18 years with various oncological diseases.
Children and adolescents aged 12 years and over with advanced (unresectable or metastatic) melanoma
- The additional benefit is not proven.
- For children and adolescents aged 12 years and over with advanced (unresectable or metastatic) melanoma, the pharmaceutical manufacturer was unable to identify any randomised controlled trial directly comparing pembrolizumab with the appropriate comparator therapy.
- The descriptive data presented from the KEYNOTE 051 study are not suitable for drawing conclusions regarding the additional benefit of pembrolizumab in children and adolescents aged 12 years and over with advanced melanoma compared with the appropriate comparator therapy.
- Morbidity – Treatment response
- For the five patients, the pharmaceutical manufacturer presented the results for the endpoints ‘response to treatment’ and ‘adverse events’ in descriptive form.
- The pharmaceutical manufacturer states that, due to the small number of patients, it is not possible to draw any conclusions regarding the efficacy of pembrolizumab.
- Side effects – adverse events
- The pharmaceutical manufacturer provided the results for the endpoints ‘response to treatment’ and ‘adverse events’ for the five patients in descriptive form.
- Summary of the assessment
- The pharmaceutical manufacturer provided individual data from the KEYNOTE 051 trial, in which children and adolescents with various oncological diseases were treated with pembrolizumab. Of these, 9 patients have advanced melanoma, with 5 belonging to the age group under consideration here (aged 12 years and over). For these 5 patients, the pharmaceutical manufacturer provided results on treatment response and adverse events in descriptive form. These data are not suitable for demonstrating additional benefit.
- Overall, there are no suitable data available to enable an assessment of the additional benefit of pembrolizumab in children and adolescents aged 12 years and over with advanced melanoma compared with the appropriate comparator therapy. The additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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