Roche’s new Herceptin jab approved by NHS
pharmafile | September 25, 2013 | News story | Sales and Marketing | Herceptin, Kadcyla, Roche, breast cancer
The NHS has approved Roche’s new injectable form of its ageing breast cancer drug Herceptin, potentially slashing treatment times for thousands of patients.
The jab received European regulatory authorisation in September, after a Phase III trial demonstrated comparable effectiveness to intravenously-administered Herceptin (trastuzumab).
The primary advantage of this new form of the drug is that it takes two to five minutes to administer, as opposed to the 30-90 minutes required for IV treatment. Roche claims this will contribute to savings of up to £20 million for the health service.
The injection is also likely improve treatment experience for patients who find the lengthy IV process invasive. Herceptin is typically administered once every three weeks over the course of about 12 months.
University of Sussex cancer specialist Lesley Fallowfield said: “If subcutaneous delivery of Herceptin were to replace intravenous administration in the NHS then patients would spend less time in hospital and more time getting on with their lives.”
Herceptin is a monoclonal antibody designed to target HER2-positive breast cancer, an aggressive form of the disease that constitutes 15-20% of cases. It works by inhibiting HER2 receptors in cancer cells, suppressing tumour growth.
The drug is the market leader for breast cancer treatment, with sales of over £4 billion in 2012 alone. However, its European patent is due to expire in 2014, which has prompted Roche to develop different versions and new extensions of the drug.
Data from a Phase III trial of Kadcyla (trastuzumab emtansine) is expected to be announced at this month’s European Cancer Congress. The new product is an antibody-drug conjugate that combines Herceptin and cancer cell-killing compound emtansine.
As it has shown advantages over Herceptin, the drug could take the edge off its predecessor’s impending sales drop. Kadcyla has already gained US approval from the FDA, with analysts predicting peak annual sales of up to £3 billion.
According to charity Cancer Research UK, there were nearly 50,000 new British cases of breast cancer in 2010. Despite its rarity in men, it remains the most common type of cancer in the UK, and claims nearly 12,000 lives every year.
Hugh McCafferty
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