Svoboda | Graniru | BBC Russia | Golosameriki | Facebook
Jump to content

Pertuzumab/trastuzumab/hyaluronidase

From Wikipedia, the free encyclopedia
(Redirected from Pertuzumab/trastuzumab)

Pertuzumab/trastuzumab/hyaluronidase
Combination of
PertuzumabHER2/neu receptor antagonist
TrastuzumabHER2/neu receptor antagonist
HyaluronidaseEndoglycosidase
Clinical data
Trade namesPhesgo
AHFS/Drugs.comMonograph
License data
Pregnancy
category
  • Not recommended
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

Pertuzumab/trastuzumab/hyaluronidase, sold under the brand name Phesgo, is a fixed-dose combination medication to treat adults with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adults with early HER2-positive breast cancer.[5][6] It contains pertuzumab, trastuzumab, and hyaluronidase–zzxf.[5] It is injected under the skin via subcutaneous injection in the thigh.[5] In the European Union, Phesgo contains the active ingredients pertuzumab and trastuzumab along with the enzyme vorhyaluronidase alfa.[7]

The most common side effects include alopecia (hair loss), nausea, diarrhea, anemia (reduced number of red blood cells) and asthenia (lack of energy).[5][8][3] It can cause worsening of chemotherapy induced neutropenia (low level of white blood cells).[5] It may cause harm to a developing fetus or a newborn baby.[5]

HER2-positive breast cancer, which makes up approximately one-fifth of breast cancers, has too much of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells.[5] Pertuzumab and trastuzumab bind to sites on HER2 and disrupt signaling to stop cancer cell growth.[5]

Medical uses

[edit]

The fixed-dose combination is indicated for the treatment of early breast cancer (EBC):

  • Use in combination with chemotherapy for:[8]
    • the neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer;[8]
    • the adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.[8]

and for the treatment of metastatic breast cancer (MBC):

  • Use in combination with docetaxel for the treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.[8]

Adverse effects

[edit]

The FDA label includes a boxed warning about the risk of potential heart failure, fetal harm, and lung toxicity.[5][9]

History

[edit]

The fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase was approved for medical use in the United States in June 2020.[5][10]

The FDA's approval was based on the results of a non-inferiority study in participants with HER2-positive early breast cancer, which demonstrated the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase had comparable efficacy and safety as IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with the fixed-dose combination due to the subcutaneous route of administration.[5]

Efficacy was investigated in FeDeriCa (NCT03493854), an open-label, multicenter, randomized trial enrolling 500 participants with operable or locally advanced HER2-positive breast cancer.[8] Participants were randomized to receive neoadjuvant chemotherapy with concurrent administration of either the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase or intravenous pertuzumab and intravenous trastuzumab during the neoadjuvant and adjuvant therapies.[8]

The primary endpoint of FeDeriCa was non-inferiority of cycle 7 pertuzumab serum trough concentration comparing the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase to intravenous pertuzumab.[8] Secondary endpoints included cycle 7 trastuzumab serum trough concentration, pathological complete response (pCR), and safety.[8] The fixed-dose combination showed non-inferior pertuzumab and trastuzumab serum trough concentrations compared to intravenous pertuzumab and trastuzumab.[8] The pCR rate was 59.7% (95% CI: 53.3, 65.8) in the pertuzumab/trastuzumab/hyaluronidase arm and 59.5% (95% CI: 53.2, 65.6) in the intravenous pertuzumab and intravenous trastuzumab arm.[8] The safety profile of the fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase is comparable to intravenous pertuzumab and trastuzumab, except for increased administration-related reactions.[8]

The FDA granted approval of Phesgo to Genentech Inc.[5]

Society and culture

[edit]
[edit]

On 12 November 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Phesgo, intended for the treatment of early and metastatic breast cancer.[11] The applicant for this medicinal product is Roche Registration GmbH.[11] Phesgo was approved for medical use in the European Union in December 2020.[3]

References

[edit]
  1. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  2. ^ "Phesgo- pertuzumab, trastuzumab, and hyaluronidase-zzxf injection, solution". DailyMed. Retrieved 22 October 2021.
  3. ^ a b c "Phesgo EPAR". European Medicines Agency (EMA). 13 October 2020. Retrieved 14 January 2021.
  4. ^ "Phesgo Product information". Union Register of medicinal products. Retrieved 3 March 2023.
  5. ^ a b c d e f g h i j k l This article incorporates text from this source, which is in the public domain.
  6. ^ Skidmore-Roth L (2021). "Pertuzumab/trastuzumab/hyaluronidase-zzxf (Rx)". Mosby's Drug Guide for Nursing Students with 2022 Update - E-Book (14th ed.). Elsevier Health Sciences. p. 1213. ISBN 978-0-323-87656-8.
  7. ^ "Phesgo 600 mg/600 mg solution for injection" (PDF). Roche Pharma AG. European Medicines Agency. 21 December 2020.
  8. ^ a b c d e f g h i j k l This article incorporates text from this source, which is in the public domain.
  9. ^ "Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, for subcutaneous use" (PDF). Genentech, Inc. Retrieved 29 June 2020.
  10. ^ "FDA approves Roche's Phesgo (fixed-dose combination of Perjeta and Herceptin for subcutaneous injection) for HER2-positive breast cancer". F. Hoffmann-La Roche Ltd (Press release). 29 June 2020. Retrieved 29 June 2020 – via GlobeNewswire.
  11. ^ a b "Phesgo: Pending EC decision". European Medicines Agency (EMA). 11 November 2020. Archived from the original on 20 November 2020. Retrieved 13 November 2020.

Further reading

[edit]
[edit]
  • Clinical trial number NCT03493854 for "A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer (FeDeriCa)" at ClinicalTrials.gov
Retrieved from "https://en.wikipedia.org/w/index.php?title=Pertuzumab/trastuzumab/hyaluronidase&oldid=1234593176"