New Herceptin data sways NICE
pharmafile | September 30, 2010 | News story | Sales and Marketing | Herceptin, NICE, Roche
NICE is now minded to approve Roche’s Herceptin for patients with metastatic gastric cancer after receiving new efficacy data from the manufacturer.
Back in July NICE said in draft guidance that it could not recommend Herceptin (trastuzumab) “due to the uncertainty surrounding the extent to which to which it can extend life”.
Since then Roche has provided new data that persuaded the cost-effectiveness body of the drug’s worth in a subgroup of patients.
Andrew Dillon, chief executive of NICE, said: “During consultation on the first draft guidance, Roche submitted a new analysis on a subgroup of patients with the highest levels of HER2.
“The Committee discussed this new information and concluded that trastuzumab was cost-effective in this patient group. The Committee also agreed that trastuzumab for this group of patients fitted the criteria for consideration for appraising a life-extending, end-of-life treatment.”
The new draft guidance recommends Herceptin’s use in combination with chemotherapy agents cisplatin and capecitabine or 5-fluorouracil, for the treatment of people with HER2-positive, metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, who have not received prior treatment for their metastatic disease.
NICE recommends that it can also be used in patients whose tumours express high levels of HER2 as defined by a positive immunohistochemistry score of 3 (IHC3 positive).
The drug was approved by the EMA back in January on the basis of the ToGA trial that saw patients using Herceptin plus chemotherapy gain on average an overall survival of 16 months, versus 11.8 months on chemotherapy alone.
The drug works by targeting the human epidermal growth factor receptor (HER2), a protein found on the surface of some cancer cells. Herceptin attaches itself to the HER2 protein so that epidermal growth factor cannot reach the cancer cells; this stops the cells from dividing and growing but can only work in people who have high levels of the HER2 protein.
Gastric cancer affects around 8,200 people in the UK every year, of whom approximately 500 would be suitable for treatment with Herceptin. Current average life expectancy in patients with the disease is less than two years.
Herceptin is already indicated and NICE approved for HER2-positive metastatic breast cancer patients and is Roche’s third biggest selling drug after Avastin and MabThera, making CHF 5.3 billion in sales last year.
NICE’s final appraisal determination (FAD) is available here.
Ben Adams
Related Content
Digital mental health technologies – a valuable tool in supporting people with depression and anxiety
The potential benefits of digital mental health technology for managing depression, anxiety and stress, together …
Combination treatments: Takeda’s Implementation Framework and the broader landscape
Pharmafile talks to Emma Roffe, Oncology Country Head (UK & Ireland) about the combination treatment …
Roche receives CE Mark for blood test to help rule out Alzheimer’s
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in …
