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)
ICD-10 codes (AIS) C50.0Malignant neoplasm of nipple and areola, C50.1Malignant neoplasm of central portion of breast, C50.2Malignant neoplasm of upper-inner quadrant of breast, C50.3Malignant neoplasm of lower-inner quadrant of breast, C50.4Malignant neoplasm of upper-outer quadrant of breast, C50.5Malignant neoplasm of lower-outer quadrant of breast, C50.6Malignant neoplasm of axillary tail of breast, C50.8Malignant neoplasm of overlapping sites of breast, C50.9Malignant neoplasm of breast of unspecified site
Alpha-ID codes (AIS) I102868Malignant neoplasm of the outer 2 quadrants of the mammary gland, I102970Malignant neoplasm of the upper inner quadrant of the mammary gland, I102971Malignant neoplasm of the lower inner quadrant of the mammary gland, I102972Malignant neoplasm of the upper outer quadrant of the mammary gland, I102973Malignant neoplasm of the lower outer quadrant of the mammary gland, I102998Malignant neoplasm of the central glandular body of the mammary gland, I102999Malignant neoplasm of the axillary recess of the mammary gland, I111628Malignant neoplasm of the nipple and areola, I18060Metastatic breast cancer
DDD 0.05 P
Therapeutic area Oncological diseases Mammary carcinoma / Breast cancer (BC)
Reason for procedure Initial assessment
Specialty Bundling

Therapeutic indication of the resolution

Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Subpopulation Indication Comparator
Adult patients with HER2-positive metastatic or locally recurrent, unresectable breast cancer who have not previously received anti-HER2 therapy or chemotherapy for the treatment of metastatic disease. Pertuzumab in combination with trastuzumab and docetaxel

Studies and Results

No. of studies
(best subpopulation) 		1 (CLEOPATRA) 0 (Data not accepted)
Study design
(best subpopulation) 		Data not accepted (Dossier: H2H vs. non-ACT + no ITC)

  • 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



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