The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Roche's breast cancer treatment pertuzumab (brand name Perjeta) for treating early HER2-positive breast cancer in people whose disease has spread to their lymph nodes. .
NICE state that 'this positive recommendation is for people who have had surgery for their breast cancer and whose cancer has already spread to their lymph nodes. The estimated 2700 people in this subgroup have a higher risk of their cancer returning.
The evidence shows that adding pertuzumab to trastuzumab and chemotherapy after surgery increased the proportion of people whose disease didn’t spread. However, there is a lack of evidence on how long, if at all, adding pertuzumab might increase the overall length of time people live.'
Pertuzumab, with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if:
- they have lymph-node-positive disease
- the company provides it according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.
A final decision is expected to be published on 20th March 2019.
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Why the committee made these recommendations
There is uncertainty about the size of the clinical benefit for pertuzumab in the adjuvant treatment of HER2-positive early stage breast cancer at high risk of recurrence. Clinical trial evidence measuring invasive disease-free survival suggests that 1.7% fewer people with this type of cancer have invasive disease at 4 years with adjuvant pertuzumab. Evidence from people with lymph-node-positive disease (that is, disease that has spread to lymph nodes in the armpit) suggests more benefit in this population, with 3.2% fewer people having invasive disease at 4 years.
However, it is not known whether this means that adjuvant pertuzumab increases the overall length of time people live.
About Perjeta (source EMA)
Perjeta is a cancer medicine for treating adults with ‘HER2-positive’ breast cancer (where a protein called HER2 is found on the cancer cells). Perjeta is used in the following situations:
- treatment of metastatic breast cancer (cancer that has spread to other parts of the body) that has not already been treated with chemotherapy medicines or medicines designed to target HER2, or for breast cancer that has come back locally after treatment and cannot be removed by surgery. In these cases, Perjeta is used with trastuzumab and docetaxel (other cancer medicines);
- treatment of locally advanced, inflammatory or early-stage breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, before the patient undergoes surgery;
- treatment of early breast cancer at high risk of coming back, in combination with trastuzumab and chemotherapy, after the patient has had surgery
The active substance in Perjeta, pertuzumab, is a monoclonal antibody, a type of protein that has been designed to attach to HER2, a protein found on 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 (the body’s natural defences), which then kill the cancer cells.
Perjeta was first made available in the EU in 2013. It is manufactured by Roche.
European Medicines Agency website page for Perjeta
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© NICE  Pertuzumab for adjuvant treatment of early HER2-positive breast cancer (ID1192) Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
The information provided by NICE was accurate at the time this article was issued.
NICE guidance on Perjeta for treating breast cancer
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