Monday, October 09, 2006

Glaxo Files Tykerb in Europe

Just a month after filing the NDA for Tykerb in US, Glaxo has filed for its approval in Europe. Tykerb or lapatinib, a small molecule HER2 inhibitor, has been studied in breast cancer in patients who failed Herceptin treatment. In patients who failed Herceptin treatment, Tykerb, incombination with Xeloda was found to double to Time to Progression. This from the Glaxo press release...
....Phase III international, multicenter, open-label trial randomized 324 women who had advanced or metastatic breast cancer with documented HER2 overexpression and whose disease progressed following treatment with Herceptin and other cancer therapies, to TYKERB and Xeloda or Xeloda alone. In this pivotal trial, the combination of TYKERB and Xeloda versus Xeloda alone nearly doubled median time to progression (36.7 weeks [8.5 months] in the combination arm versus 19.1 weeks [4.4 months] with Xeloda alone, p=0.00008).

All this is great news for the patients IF the health authorities in UK and elsewhere in Europe allow easy access to Tykerb. I can only hope that the Herceptin story is not repeated again with Tykerb.