Pertuzumab / Trastuzumab (1) – Phesgo®
Breast cancer (BC) HER2+, metastatic or locally recurrent
Characteristics
| Start date | 01.02.2021 – Marketing authorisation: 21.12.2020 |
|---|---|
| Resolution | 15.07.2021 |
| INN | Pertuzumab/Trastuzumab |
| Brand name | Phesgo® |
| Pharm. company | Roche Pharma AG |
| G-BA Procedure ID | D-630 |
| ATC code | L01FY01 MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES (L01F) |
| DDD | 0.05 P |
| Therapeutic area | Oncological diseases |
| Reason for procedure | Initial assessment |
| Specialty | Bundling |
Studies and Results
- Clinical trials
- For the benefit assessment of the subcutaneous fixed-dose combination of pertuzumab and trastuzumab, the pharmaceutical manufacturer cites the CLEOPATRA trial, which compared the free intravenous combination of pertuzumab and trastuzumab with placebo plus trastuzumab, in each case in combination with docetaxel, in adult patients with HER2-positive metastatic or locally recurrent, inoperable breast cancer who had not previously received anti-HER2 therapy or chemotherapy for the treatment of the metastatic disease.
Adult patients with HER2-positive metastatic or locally recurrent, inoperable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for the treatment of metastatic disease
- The additional benefit is not proven
- Based on the available data described, it is not possible to assess the additional benefit in the overall review. Consequently, additional benefit is not proven.
- Overall assessment
- On the basis of the data described, it is not possible to assess the additional benefit in the overall assessment. Consequently, additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Pertuzumab / Trastuzumab (4) | Phesgo® | Roche Pharma AG | Breast carcinoma (BC), HER2+, early with high risk of recurrence, adjuvant therapy, combination with chemotherapy | 1,910–3,060 | 100% Indication of minor additional benefit | |
| Pertuzumab / Trastuzumab (1) | Phesgo® | Roche Pharma AG | Breast cancer (BC) HER2+, metastatic or locally recurrent | 2,470–4,000 | 100% additional benefit not proven | |
| Pertuzumab / Trastuzumab (2) | Phesgo® | Roche Pharma AG | Breast cancer (BC) HER2+, locally advanced or inflammatory or early with high risk of recurrence, neoadjuvant | 2,690–3,450 | 100% additional benefit not proven | |
| Pertuzumab / Trastuzumab (3) | Phesgo® | Roche Pharma AG | Breast cancer (BC) early stage, HER2+, adjuvant treatment |
0
1,970–3,200 |
100% Hint for minor additional benefit repealed |
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