GlaxoSmithKline has filed its investigational oral drug pazopanib with the European Medicines Agency for approval to treat patients with advanced and/or metastatic renal cell carcinoma.
GSK says that the filing is based on positive results from a Phase III study of pazopanib, a once-daily angiogenesis inhibitor, in treatment-naive and cytokine-pre-treated patients with advanced RCC. The primary endpoint was progression-free survival and secondary endpoints included overall survival, response rate and safety. More detailed findings from the trial will be presented at an upcoming medical meeting, the company added.
Pazopanib was filed with the US Food and Drug Administration in December for the treatment of advanced RCC. GSK’s chairman of R&D, Moncef Slaoui, noted that the European filing of pazopanib “marks our fifth major submission since the formation of the R&D Oncology Unit in September 2008”. These include FDA and EMEA filings for ofatumumab, developed in partnership with Genmab.
These submissions “underscore the value of a dedicated oncology R&D unit in capturing the many synergies that exist between discovery and development in oncology and in delivering more products of value,” Dr Slaoui added.
Meantime the publication of GSK’s 2008 annual report has revealed that the company is changing its remuneration scheme to base the pay of chief executive Andrew Witty and chief financial officer Julian Heslop on UK multinational companies, as opposed to global pharmaceutical groups.
Sir Robert Wilson, chairman of the remuneration committee, stated that “at this time, at least, the proposed remuneration package of the chief executive officer would be well below the median of his pharmaceutical industry peers.” The move is being proposed, and will be voted on at GSK’s annual general meeting in May, in response to current economic situation and to better reflect the company’s UK home base.
