EU green light for ‘new’ Herceptin
pharmafile | September 3, 2013 | News story | Sales and Marketing | EU, Herceptin, Roche, breast cancer
Roche has ticked another approval off Herceptin’s list with the news that the European Commission is allowing a new form of the drug to be used in an aggressive type of breast cancer.
The big change is that the new injectable formulation of the veteran treatment can be administered to patients at least six times faster than the standard intravenous form – taking between two and five minutes rather than the 30 to 90 minutes.
The ease of use – as well as its speed, a loading dose is not required, for example – could provide a boost to the Swiss company, eking out more revenue from a treatment which has been on the market since 1998. Its European patent expires next year.
This version of Herceptin (trastuzumab) can be used to treat HER2-positive breast cancer in both early and later stages, the European regulator says, after the HannaH study showed its effect was comparable to the one currently in use.
Using technology developed by Halozyme Therapeutics, it is given as a 600 mg/5 ml fixed dose every three weeks and is likely to be popular with both doctors and sufferers.
“We are pleased this new formulation of Herceptin may enable patients to spend less time in the hospital and more time getting on with their lives,” said Hal Barron, Roche’s chief medical officer.
Roche says that research shows maintaining a normal life and spending time with friends and family can improve the wellbeing of women with the disease.
HannaH found there was comparable efficacy (pathological complete response) to intravenous Herceptin in women with HER2-positive early breast cancer. Trastuzumab plasma levels were non-inferior and the safety profile in both arms of the HannaH study was consistent with standard Herceptin and chemotherapy treatment.
More than 90,000 women in Europe are diagnosed with HER2 positive breast cancer every year and Herceptin is used to treat more than 80,000 patients each year in Europe.
Breast cancer is the most common cancer among women, with 1.4 million new cases diagnosed worldwide, and over 450,000 dying of the disease annually.
HER2-positive cancer – in which increased quantities of the human epidermal growth factor receptor 2 are present on the surface of tumour cells – is particularly aggressive and affects approximately 15-20% of women with the disease.
Roche stands to lose a whopping $6 billion a year with Herceptin’s upcoming patent loss but has another major extension of the brand up its sleeve, a so-called ‘smart bomb’ version of the drug, which was approved by the FDA earlier this year.
Kadcyla (trastuzumab emtansine or T-DM1) combines Herceptin and chemotherapy in one molecule and is the first antibody-drug conjugate for treating HER2-positive metastatic breast cancer (mBC).
Trials have shown Kadcyla significantly delayed disease progression and produced fewer side effects – and analysts believe it could make more than $1.1 billion in peak annual sales.
Adam Hill
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