Lani
06-03-2009, 09:48 AM
with brain mets, but for those progressing after prior treatments)!
Lapatinib Ditosylate Plus Capecitabine Approved for Patients With HER2+ Breast Cancer in Canada [Doctor's Guide]
NEW YORK — May 31, 2009 — Health Canada has approved lapatinib ditosylate (Tykerb) tablets for use in combination with capecitabine (Xeloda) for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 (ErbB2) and who have progressed following prior therapies including taxanes, anthracyclines, and trastuzumab (Herceptin).
The approval was based on a pivotal phase 3 trial (EGF100151) in which women with locally advanced or metastatic HER2 positive breast cancer whose disease had progressed following prior treatment with anthracyclines, taxanes, and trastuzumab were given either the combination of lapatinib ditosylate and capecitabine, or capecitabine alone.
Lapatinib ditosylate in combination with capecitabine was shown to increase the median time to progression compared with capecitabine alone. There was a consistent benefit in time to progression (TTP) by both unblinded investigator and blinded independent assessment, although the magnitude of TTP by independent assessment was likely overestimated.
Lapatinib Ditosylate Plus Capecitabine Approved for Patients With HER2+ Breast Cancer in Canada [Doctor's Guide]
NEW YORK — May 31, 2009 — Health Canada has approved lapatinib ditosylate (Tykerb) tablets for use in combination with capecitabine (Xeloda) for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress HER2 (ErbB2) and who have progressed following prior therapies including taxanes, anthracyclines, and trastuzumab (Herceptin).
The approval was based on a pivotal phase 3 trial (EGF100151) in which women with locally advanced or metastatic HER2 positive breast cancer whose disease had progressed following prior treatment with anthracyclines, taxanes, and trastuzumab were given either the combination of lapatinib ditosylate and capecitabine, or capecitabine alone.
Lapatinib ditosylate in combination with capecitabine was shown to increase the median time to progression compared with capecitabine alone. There was a consistent benefit in time to progression (TTP) by both unblinded investigator and blinded independent assessment, although the magnitude of TTP by independent assessment was likely overestimated.