GlaxoSmithKline has withdrawn one submission to expand the label on Tyverb in Europe, after the regulator expressed concerns about the data, but has filed fresh regulatory applications on both sides of the Atlantic for the breast cancer drug.
The European Medicines Agency says it has been formally notified by GSK of its decision to withdraw an application for an extension of the indication for Tyverb (lapatinib) in combination with paclitaxel for the treatment of patients with metastatic breast cancer whose tumours overexpress HER2. The company has taken this path based on an assessment by the agency's Committee for Medicinal Products for Human Use that "the lack of an active-controlled trial" with Roche's Herceptin (trastuzumab) plus paclitaxel "hampers the proper assessment of the benefit-risk balance in European patients in the applied indication".
Tyverb, known elsewhere as Tykerb, was given conditional approval in the European Union in June 2008 and is currently authorised in combination with Roche's Xeloda (capecitabine) for patients with advanced disease with progression following prior therapy. It is also available in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease.
Rafael Amado, head of GSK Oncology R&D said that in terms of the submission for Tyverb in combination with paclitaxel, "we are disappointed with the CHMP trend vote". However, regulatory review of the combo in the metastatic breast cancer setting are ongoing in other regions, he noted.
GSK then announced that it has submitted regulatory applications in Europe and the USA related to Tyverb in combination with Herceptin. The filings are for the treatment of patients with HER2-positive metastatic breast cancer that has progressed on prior treatment with the Roche blockbuster.
Dr Amado said the drug is "an important part of the GSK oncology portfolio" and the regulatory submissions for the Tyverb/Herceptin combo "demonstrate our commitment to the field of HER2 positive disease".
