GSK and Roche get EU breast cancer indication
pharmafile | August 15, 2013 | News story | Sales and Marketing | GSK, Herceptin, Roche, Tyverb, Xeloda, breast cancer
The European Commission has granted a new indication for the use of GSK’s breast cancer drug Tyverb in combination with Roche’s Herceptin.
Tyverb (lapatinib) is currently licensed for use in Europe with Roche’s Xeloda (capecitabine), a chemotherapeutic pill that helps slow the growth of tumour tissue.
President of GSK’s oncology department Paola Paoletti, said that the announcement was an important one for women with HER2 positive breast cancer, adding: “The combination of Tyverb and trastuzumab [Herceptin], has the potential to make a positive impact on the care and survival of these patients.”
Tyverb is a pill used in combination therapy with Herceptin and targets the HER2 receptors.
A Phase III trial found that together the drugs led to an 8.3 month increase in overall survival, versus Tyverb on its own.
Outside of Europe GSK licenses the compound as Tykerb. This new indication announcement will be a boost for the UK firm, which recently saw its Tykerb salt derivative patent revoked by authorities in India (its rights over the lapatinib compound itself were upheld until 2019).
The European Commission’s decision will also offer the company a competitive edge in the oncology market.
Roche’s Perjeta (pertuzumab), which targets the same type of breast cancer as Tyverb, was heralded as a future blockbuster earlier this year. However, the Swiss company’s product is used in combination with chemotherapy, so a Tyverb/Herceptin treatment regimen presents an alternative option that may appeal to many patients.
Tyverb earned £239 million worldwide last year, a growth of 6% on the previous twelve months. Sales are likely to increase if its use with Herceptin proves popular.
In the US, the drug is licensed only for use in combination with Xeloda and Novartis’ Femara (letrozole). It remains to be seen what impact the European Commission’s decision will have on future applications in that territory.
Hugh McCafferty
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