Perjeta (pertuzumab)

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Perjeta (pertuzumab)

How to buy Perjeta: You can order Perjeta (pertuzumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Genentech
Disease Breast Cancer
Indication HER2-positive breast cancer
Mode of Action HER2/neu receptor antagonist (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 9046114-94-4
HS Code 30049000
Strength 30 mg / mL

Who is pertuzumab for?

Perjeta (pertuzumab) is indicated for the treatment of HER2 positive breast cancer in patients with metastatic cancer or as neoadjuvant treatment for patients with locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer [1][2][3].
Use in combination with trastuzumab and docetaxel (other cancer medicines) for the treatment of patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease [1][2][3].
Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment for patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer as part of a complete treatment regimen for early breast cancer [1][2][3].

Recommended dose

Complete information about Perjeta (pertuzumab) dosage and administration can be found here [1][2][3].
The standard dosage is:
  • Initial dose: 840 mg administered as a 60-minute intravenous infusion
  • Following infusions: 420 mg administered as a 30 to 60-minute intravenous infusion every 3 weeks.
Patients with metastatic breast cancer should be treated with pertuzumab and trastuzumab until disease progression or unmanageable toxicity.
Patients in neoadjuvant treatment of breast cancer should be administered pertuzumab every 3 weeks for 3 to 6 cycles before surgery.
Consult your treating doctor for personalised dosing.

What is pertuzumab and how does it work?

Perjeta (pertuzumab) is a HER2/neu receptor antagonist indicated for the treatment of HER2 positive breast cancer in metastatic patients or as neoadjuvant therapy [1][2][3].
Pertuzumab is a monoclonal antibody that has been designed to recognise and attach to HER2, a protein found on the surface of HER2-positive cancer cells. By attaching to HER2, pertuzumab stops HER2 producing signals that cause the cancer cells to grow. It also activates cells of the immune system, which then kill the cancer cells [4].

What is pertuzumab's approval status?

Perjeta (pertuzumab) was approved by:
  • FDA (USA) on June 12, 2012 [5]
  • EMA (EU) on March 4, 2013 [2]
  • TGA (AUS) on May 6, 2013 [3]
for HER2 positive breast cancer in metastatic patients or as neoadjuvant therapy.
The approvals of pertuzumab for metastatic breast cancer were based on a multicentre, randomised, double-blind, placebo-controlled phase III clinical trial (CLEOPATRA - WO20698) which included 808 patients with HER2-positive metastatic or locally recurrent unresectable breast cancer. Patients received either placebo, trastuzumab and docetaxel or pertuzumab, trastuzumab and docetaxel. The addition of pertuzumab to the treatment resulted in an extension of the median progression-free survival (PFS) by over 6 months (18.5 months vs 12.4 months) [1][2][3]. The median overall survival (OS) was 56.5 months in patients who took pertuzumab compared to 40.8 in patients who didn’t. The difference in overall response rate (ORR) was 10.8 % in favour of pertuzumab (80.2 % vs. 69.3 %) with 5.5 % complete responses (vs. 4.2 %) [2][3].
The approvals of pertuzumab as neoadjuvant treatment of breast cancer was based on two studies. The first, a phase II, multicentre, multinational randomized controlled trial (NEOSPHERE - WO20697) which involved 417 patients with newly diagnosed, early, inflammatory or locally advanced HER2-positive breast cancer who had not received prior trastuzumab, chemotherapy or radiotherapy. Patients were randomised to receive one of the following neoadjuvant regimens for 4 cycles prior to surgery:
  • trastuzumab plus docetaxel
  • Perjeta (pertuzumab) plus trastuzumab and docetaxel
  • Perjeta (pertuzumab) plus trastuzumab
  • Perjeta (pertuzumab) plus docetaxel [2][3]
The pathological complete response (pCR) — defined as the absence of residual invasive disease in the breast and in the armpit lymph nodes at the completion of the neoadjuvant treatment [6] — was 39.3 % [95 % CI: 30, 49.2] in the group that took pertuzumab in combination with trastuzumab and docetaxel which was 2 to almost 4 times higher than the other combinations [2][3].
The second study (TRYPHAENA - BO22280) a multicentre, randomised phase II clinical trial, involved 225 adult female patients with HER2-positive locally advanced, operable, or inflammatory breast cancer who had not received prior trastuzumab, chemotherapy or radiotherapy. Patients were randomly allocated to receive 1 of 3 neoadjuvant regimens prior to surgery as follows:
  • 3 cycles of FEC (5-Fluorouracil, epirubicin, and cyclophosphamide) followed by 3 cycles of docetaxel all in combination with Perjeta (pertuzumab) and trastuzumab,
  • 3 cycles of FEC alone followed by 3 cycles of docetaxel and trastuzumab in combination with Perjeta (pertuzumab)
  • 6 cycles of docetaxel, carboplatin, and trastuzumab in combination with Perjeta (pertuzumab).
The highest pCR rates were achieved in the last of the three groups, with a pCR rate of 66.2% [95 % CI: 54.6; 76.6] vs 61.6 % [95 % CI: 49.5; 72.8] and 57.3% [95 % CI: 45.4; 68.7] in the first and second group, respectively [2][3].
References
[1] Summary of Product Characteristics [FDA]: Perjeta (pertuzumab), Genentech, Sep. 2013.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf
[2] Summary of Product Characteristics [EMA]: Perjeta (pertuzumab), Roche, Oct. 2016.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002547/WC500140980.pdf
[3] Summary of Product Characteristics [TGA]: Perjeta (pertuzumab), Roche, Aug. 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2013-PI-01655-1
[4] EMA: Human Medicines: Perjeta (pertuzumab), 02/04/2013, (last update: 20/110/2016), cited on 20/06/2017.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002547/human_med_001628.jsp&mid=WC0b01ac058001d124
[5] Roche Media Release. FDA approves Perjeta (pertuzumab) for people with HER2-positive metastatic breast cancer, 11/06/2012.
http://www.roche.com/media/store/releases/med-cor-2012-06-11.htm
[6] Sikov W.M. Relevance of pCR in Breast Cancer Trials. Cancer Network. 09/09/2014.
http://www.cancernetwork.com/asco-2014-breast-cancer-symposium/relevance-pathologic-complete-response-breast-cancer-trials








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