Pertuzumab (Perjeta; Genentech) has been approved for routine use in the NHS in England for women with HER2-positive metastatic or recurrent inoperable breast cancer.
The decision follows a deal reached over the price of the drug between the manufacturer Roche and NHS England, and also takes into account additional follow-up data from the key randomised trial.
Welsh cabinet secretary for health Vaughan Gething has confirmed that the drug will also be made available by health boards in Wales within 60 days under the country’s New Treatment Fund.
The drug is recommended, in combination with trastuzumab (Herceptin) and docetaxel, for treating HER2-positive metastatic or locally recurrent unresectable breast cancer in patients who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Evidence provided by Genentech parent company Roche included data from the randomised, placebo-controlled trial known as CLEOPATRA. This involved 808 adults with HER2-positive metastatic breast cancer from 25 different countries. They were randomly assigned to receive pertuzumab or placebo (every three weeks) in addition to trastuzumab and docetaxel.
The trial showed that overall survival was increased by almost 16 months with pertuzumab, at 56.5 months versus 40.8 in the placebo group. Median progression-free survival was also increased by 6.3 months.
Pertuzumab has previously been approved by NICE to shrink HER-positive tumours before surgical removal.
Pertuzumab was previously rejected by NICE for routine funding in advanced disease and has been available through the Cancer Drugs Fund since 2013. It is received by around 1300 patients per year. This latest appraisal was resumed as part of changes to the new Cancer Drugs Fund introduced last year.
The drug has also previously been rejected by the Scottish Medicines Consortium (SMC), meaning it will not be routinely available in Scotland.
The charity Breast Cancer Now is calling for urgent action to rectify the cross-border disparity.
Lawrence Cowan, policy and campaigns manager for Breast Cancer Now in Scotland, said: “We need urgent talks to break this deadlock and for Roche, the SMC and Scottish government to work together to find a solution for Scottish patients.”