LONDON (Reuters) Sep 09 - Breast cancer patients in a phase III trial will stop getting GlaxoSmithKline's Tykerb (lapatinib) alone after an independent committee decided the drug was likely to produce worse results that Roche's Herceptin (trastuzumab).
The British drugmaker said the other three arms of the trial -- which is designed to examine the performance of Tykerb in combination with Herceptin -- would continue as planned.
"The (independent data monitoring) committee has indicated that the lapatinib alone arm is unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival," GSK said in a statement on Friday.
Tykerb is marketed as Tyverb in Europe. Both it and Herceptin are designed for women with HER2-positive breast cancer and are given alongside standard chemotherapy.
Patients in this trial, known as ALTTO, were originally randomized to receive either Tykerb alone, Herceptin alone, Herceptin followed by Tykerb, or a combination of the two drugs together.
GSK said patients assigned to the lapatinib alone arm of the trial would discontinue the drug and discuss treatment options with their doctors
The British drugmaker said the other three arms of the trial -- which is designed to examine the performance of Tykerb in combination with Herceptin -- would continue as planned.
"The (independent data monitoring) committee has indicated that the lapatinib alone arm is unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival," GSK said in a statement on Friday.
Tykerb is marketed as Tyverb in Europe. Both it and Herceptin are designed for women with HER2-positive breast cancer and are given alongside standard chemotherapy.
Patients in this trial, known as ALTTO, were originally randomized to receive either Tykerb alone, Herceptin alone, Herceptin followed by Tykerb, or a combination of the two drugs together.
GSK said patients assigned to the lapatinib alone arm of the trial would discontinue the drug and discuss treatment options with their doctors
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