The Scottish Medicines Consortium (SMC) has granted approval for herceptin (trastuzumab) for routine use in the NHS to treat patients in Scotland with an advanced and incurable form of gastric cancer (stomach and gastro-oesophageal).
Approved under the SMC’s new patient and clinician engagement (PACE) process, herceptin has been indicated for use in combination with chemotherapy (capecitabine or 5-fluorouracil and cisplatin) for previously untreated patients with HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction.
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The approval is based on data from an open-label, international, randomised controlled Phase III Trastuzumab for Gastric Cancer (ToGA) trial.
Herceptin is a humanised, targeted antibody designed to hunt HER2 and block the ‘survive and multiply’ signals it sends directly into the cell.
OCHRE charity campaign director Kate Cunningham said: "The approval of Herceptin by the SMC today is extremely positive news for Scottish patients with this rare and incurable type of gastric cancer.
"The prognosis has been typically poor and patients are often given only a year to live from diagnosis. We’ve seen only marginal medical progress in this area for two decades and as such, there has been high unmet need for new treatment options.
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By GlobalData"When medicines show they can prolong survival, it is vital that patients can immediately benefit from them."
The ToGA trial showed that the Herceptin combination prolongs the lives of certain patients by nearly half a year (5.6 months) in the pre-planned analysis, representing a 45.2% increase in median life-expectancy, compared with the current standard of care, chemotherapy alone.
NHS Tayside consultant medial oncologist University of Dundee Medical Oncology professor Russell Petty said: "This approval has been much anticipated for patients and clinicians in Scotland.
"The Herceptin combination has been shown to extend survival and control cancer for significantly longer than the current standard of care. showing a magnitude of benefit never seen before, it is a genuine breakthrough in the treatment of gastric cancer.
"It is also encouraging to see that the PACE process has allowed Scottish patients to access this treatment, in line with the rest of the UK.
"This approval marks a much needed significant step forward in the treatment of this form of cancer in Scotland."
When used in combination with chemotherapy, herceptin has been shown to have a manageable tolerability profile.
