GlaxoSmithKline files for Tykerb/Tyverb with trastuzumab in USA and Europe

UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday that it has submitted regulatory applications in Europe and the USA related to Tykerb/Tyverb (lapatinib) and its use in combination with trastuzumab to treat patients with HER2 (ErbB2)-positive metastatic breast cancer.

 *  a variation to the Marketing Authorization Application to the European Medicines Agency for Tyverb (lapatinib) in combination with trastuzumab for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer that has progressed on prior trastuzumab regimens.

 *  a supplemental New Drug Application to the US Food and Drug Administration for Tykerb (lapatinib) in combination with trastuzumab for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy.

"Tykerb/Tyverb is an important part of the GSK oncology portfolio and the regulatory submissions in the EU and USA for Tykerb/Tyverb in combination with trastuzumab demonstrate our commitment to the field of HER2 positive disease." said Rafael Amado, senior vice president, GSK Oncology R&D.

The news comes just after GSK decided to withdraw an application under review with the European Medicines Agency for Tyverb in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2 (see separate story today).