GlaxoSmithKline pulls sNDA for Tykerb plus Herceptin; Watson/Actavis update

UK pharma giant GlaxoSmithKline (LSE: GSK) revealed yesterday that it has withdrawn a supplemental New Drug Application to the US Food and Drug Administration for Tykerb (lapatinib) in combination with trastuzumab (Roche’s Herceptin) for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy.

Regulatory reviews are ongoing in the European Union and other regions, GSK noted. An FDA advisory committee had been scheduled to consider the use of the Tykerb and Herceptin combination for patients with metastatic breast cancer whose tumors over-express the HER2 protein and who have had prior Herceptin treatment at a July 24 meeting.

“Our discussions with FDA highlighted questions that could not be addressed with the data currently available.” said Rafael Amado, head of oncology R&D for GlaxoSmithKline, adding: “We have decided to withdraw our application in the USA with the intent to wait for ongoing studies testing the combination of lapatinib with trastuzumab.”