GSK pulls Tyverb extension in Europe
pharmafile | February 17, 2012 | News story | Sales and Marketing | GSK, Herceptin, Tyverb, Xeloda
GlaxoSmithKline has withdrawn its European application to extend the licence of its breast cancer pill Tyverb.
The firm was seeking a new indication for Tyverb (lapatinib), in combination with paclitaxel, for patients with metastatic breast cancer whose tumours over-express HER2.
The decision follows an assessment from the Committee for Medicinal Products for Human Use (CHMP) this week.
It said that the lack of a direct comparison to Roche’s established HER2 breast cancer drug Herceptin (trastuzumab), plus paclitaxel, “hampered the proper assessment of the benefit-risk in European patients in the applied indication”.
Tyverb was licensed in 2008 for advanced HER2 positive breast cancer, in combination with Roche’s Xeloda (capecitabine), following previous treatment including an anthracycline and a taxane, and following treatment with Herceptin.
It can also be used to in combination with an aromatase inhibitor in women who have been through the menopause, when the cancer is metastatic and responds to hormones.
Rafael Amado, senior vice president of GSK oncology R&D, said: “In terms of our submission for Tyverb in combination with paclitaxel, we are disappointed with the CHMP trend vote and have decided to withdraw the application.
“However, regulatory review of submissions for the combination of Tyverb and paclitaxel in the metastatic breast cancer setting are ongoing in other regions.”
Tyverb made $231m for GSK last year, whilst Roche’s Herceptin made $5.3 billion in the same period.
If you can’t beat them, join them
A Tyverb study from last year was halted when an independent committee found it was likely to produce worse results when used alone than Herceptin.
Put together with this week’s decision from the CHMP, the firm has now decided to seek new licences alongside Roche’s blockbuster.
As it announced the pulling of one licence extension, the firm has said it has now submitted a separate extension in Europe and the US to review the use of Tyverb in combination with Herceptin.
The filings are for the treatment of patients with HER2-positive metastatic breast cancer that has progressed on prior treatment with Roche’s drug.
Ben Adams
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