Difference between revisions of "Pertuzumab and Trastuzumab hyaluronidase (Phesgo)"
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==General information== | ==General information== | ||
A combination of pertuzumab and trastuzumab, to be given by subcutaneous injection | A combination of pertuzumab and trastuzumab, to be given by subcutaneous injection | ||
| + | |||
| + | ==Diseases for which it is established== | ||
| + | *[[Breast cancer, HER2-positive|HER2+ breast cancer]] | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2020-06-29: Initial approval in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage [[breast cancer]] (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. ''(Based on NeoSphere, TRYPHAENA, BERENICE, APHINITY, FeDeriCa)'' |
| + | *2020-06-29: Initial approval in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early [[breast cancer]] at high risk of recurrence. ''(Based on NeoSphere, TRYPHAENA, BERENICE, APHINITY, FeDeriCa)'' | ||
| + | *2020-06-29: Initial approval in combination with docetaxel for treatment of patients with HER2 positive metastatic [[breast cancer]] (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. ''(Based on CLEOPATRA & FeDeriCa)'' | ||
| + | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | *12 | + | *2020-12-21: Initial authorization |
| + | |||
| + | ==History of changes in PMDA indication== | ||
| + | *2023-09-25: New combination drugs with a new active ingredient indicated for the treatment of HER2-positive [[breast cancer]]. | ||
| + | *2023-09-25: New combination drugs with a new active ingredient indicated for the treatment of unresectable advanced or recurrent HER2-positive [[Colorectal cancer|colon or rectal cancer]] that has progressed after cancer chemotherapy. | ||
| + | |||
==Also known as== | ==Also known as== | ||
*'''Generic name:''' pertuzumab/trastuzumab/hyaluronidase-zzxf | *'''Generic name:''' pertuzumab/trastuzumab/hyaluronidase-zzxf | ||
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[[Category:Anti-HER2 antibodies]] | [[Category:Anti-HER2 antibodies]] | ||
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| + | [[Category:Breast cancer medications]] | ||
[[Category:EMA approved in 2020]] | [[Category:EMA approved in 2020]] | ||
[[Category:FDA approved in 2020]] | [[Category:FDA approved in 2020]] | ||
| + | [[Category:PMDA approved in 2023]] | ||
[[Category:Stub]] | [[Category:Stub]] | ||
Latest revision as of 04:00, 1 June 2024
General information
A combination of pertuzumab and trastuzumab, to be given by subcutaneous injection
Diseases for which it is established
History of changes in FDA indication
- 2020-06-29: Initial approval in combination with chemotherapy as neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. (Based on NeoSphere, TRYPHAENA, BERENICE, APHINITY, FeDeriCa)
- 2020-06-29: Initial approval in combination with chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. (Based on NeoSphere, TRYPHAENA, BERENICE, APHINITY, FeDeriCa)
- 2020-06-29: Initial approval in combination with docetaxel for treatment of patients with HER2 positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. (Based on CLEOPATRA & FeDeriCa)
History of changes in EMA indication
- 2020-12-21: Initial authorization
History of changes in PMDA indication
- 2023-09-25: New combination drugs with a new active ingredient indicated for the treatment of HER2-positive breast cancer.
- 2023-09-25: New combination drugs with a new active ingredient indicated for the treatment of unresectable advanced or recurrent HER2-positive colon or rectal cancer that has progressed after cancer chemotherapy.
Also known as
- Generic name: pertuzumab/trastuzumab/hyaluronidase-zzxf
- Brand name: Phesgo