EMA Updates Prescribing Information of Breast Cancer Medicine while Data are Re-Analyzed

May 1, 2019

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.

The European Medicines Agency (EMA) has revealed in an April 30, 2019 press release that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.

In a study, which involved postmenopausal women who had HR+/HER2+ breast cancer and whose disease had worsened despite treatment with trastuzumab, it was indicated that there was a benefit of Tyverb treatment over trastuzumab when each was used in combination with an aromatase inhibitor. The erroneous study results were included in prescribing information for Tyverb on July 30, 2018, which the agency state will now be amended while data are re-analyzed.

The prescribing information will revert to the previous version, which states that no data are available on the effectiveness of Tyverb compared with trastuzumab in combination with an aromatase inhibitor. As a result of the new information, the agency specified that doctors should decide on whether or not to continue with Tyverb in combination with an aromatase inhibitor in patients whose disease has worsened despite previous treatment with trastuzumab on a case-by case basis.

Source: EMA