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.