Talimogen laherparepvec (1) – Imlygic®
Melanoma, stage IIIB, IIIC, IVMI1a
Characteristics
| Start date | 15.06.2016 – Marketing authorisation: 16.12.2015 |
|---|---|
| Resolution | 15.12.2016 |
| INN | Talimogen laherparepvec |
| Brand name | Imlygic® |
| Pharm. company | Amgen GmbH |
| G-BA Procedure ID | D-237 |
| ATC code | L01XL02 OTHER ANTINEOPLASTIC AGENTS (L01X) |
| 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 | 0.14 U P |
| Therapeutic area | Oncological diseases Melanoma (MA) |
| Reason for procedure | Initial assessment |
| Regulatory status | ATMP |
| Specialty | ACT change |
| Therapeutic indication of the resolution |
|---|
|
Imlygic is indicated for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| 1a) | Treatment of adults with unresectable, locally or distantly metastatic melanoma (stage IIIB, IIIC and IVM1a) without bone, brain, lung or other visceral involvement: Non-pretreated patients with BRAF V600 mutated tumour | Vemurafenib or vemurafenib in combination with cobimetinib or dabrafenib in combination with trametinib |
| 1b) | Treatment of adults with unresectable, locally or distantly metastatic melanoma (stage IIIB, IIIC and IVM1a) without bone, brain, lung or other visceral involvement: Non-pretreated patients with BRAF V600 wild-type tumour: | Pembrolizumab or nivolumab |
| 2) | Treatment of adults with unresectable, locally or distantly metastatic melanoma (stage IIIB, IIIC and IVM1a) without bone, brain, lung or other visceral involvement: Pre-treated patients: | Patient-specific therapy |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
| Reason for dividing into subpopulations (G-BA) | Previous treatment, Gene/mutation specifics |
| ACT change | 29.11.2016 – nach Dossiereinreichung, Stellungnahmeverfahren; neuer Therapiestandard (EBM) |
- Clinical trials
- The aim of this study was to investigate the efficacy and safety of intralesional treatment with talimogen laherparepvec compared with subcutaneously administered granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with unresectable melanoma.
- The analyses presented are limited to the patient population of study patients with stage IIIB, IIIC and IVMIa disease, for whom marketing authorisation was subsequently granted.
a) Previously untreated patients with a BRAF V600-mutated tumour
- The additional benefit is not proven.
- On the basis of the study presented, it is not possible to make comparative statements regarding additional benefit, either for previously untreated patients with a BRAF V600-mutated tumour or for patients with a BRAF V600 wild-type tumour, in relation to the respective appropriate comparator therapy determined by the G-BA, namely vemurafenib and ipilimumab, respectively.
- Nor is a descriptive comparison of the results of the OPTiM study with various pivotal studies on active ingredients authorised for the therapeutic indication and commonly used in therapy adequate.
- Taking into account the available targeted therapy options for treating the different patient populations within the indication, it is therefore not possible, on balance, to establish any additional benefit for either of the two patient populations compared with the appropriate therapies in the therapeutic indication, as determined by the currently recognised state of medical knowledge.
b) Previously untreated patients with a BRAF V600 wild-type tumour
- The additional benefit is not proven.
- On the basis of the study submitted, it is not possible to make comparative statements regarding additional benefit, either for previously untreated patients with a BRAF V600-mutated tumour or for patients with a BRAF V600 wild-type tumour, compared with the respective appropriate comparator therapy determined by the G-BA, namely vemurafenib and ipilimumab, respectively.
- Nor is a descriptive comparison of the results of the OPTiM study with various pivotal studies on active ingredients authorised for the therapeutic indication and commonly used in clinical practice adequate.
- Taking into account the available targeted therapy options for treating the different patient populations within the indication, it is therefore not possible, on balance, to establish any additional benefit for either of the two patient populations compared with the appropriate therapies in the therapeutic indication, as determined by the currently recognised state of medical knowledge.
c) Previously treated patients
- An additional benefit is not proven.
- Furthermore, the comparator GM-CSF used in the OPTiM registration trial is not part of a patient-specific treatment regimen as determined by the treating doctor.
- The study cannot therefore be used to assess the additional benefit of talimogen laherparepvec in previously treated patients with malignant melanoma.
- There is no marketing authorisation for a medicinal product containing the active ingredient GM-CSF, neither for this indication nor in general.
- GM-CSF is not currently standard practice in clinical care and was not so at the time the study was conducted.
- The experts consulted by the EMA as part of the authorisation procedure also expressed criticism of the chosen comparator.
- Consequently, even for pre-treated patients, it is not possible to establish any additional benefit compared with the therapies considered appropriate for the therapeutic indication according to the currently recognised state of medical knowledge.
Courtesy translation only, please refer to the German original.
Associated procedures
| Talimogen laherparepvec (1) | Imlygic® | Amgen GmbH | Melanoma, stage IIIB, IIIC, IVMI1a | 375–620 | 100% additional benefit not proven |
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