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GlaxoSmithKline (GSK) is to be allowed to press for UK approval of its breast-cancer drug Tyverb (lapatinib).
This follows a decision by the National Institute for Health and Clinical Excellence (NICE) to review its previous “negative guidance”.
An appeal panel says that GSK should be allowed to make a full submission under new “end of life” criteria following recent advice concerning patients with short life expectancies.
This has provided fresh hope for up to 2,000 women in the UK who are suffering from an aggressive form of advanced breast cancer (ErbB2-positive).
Says Dr Alison Jones, medical oncologist at University College London Hospital and the Royal Free Hospital: “There is a significant unmet medical need for women with this aggressive form of advanced breast cancer.
“These women have very few treatment options left, and lapatinib, when combined with capecitabine, offers a chance of additional time without their disease progressing.”
Meanwhile, GSK says it will will continue to offer the Tyverb Patient Access Programme, under which the company bears the cost of lapatinib for up to the first 12 weeks of treatment.
Copyright Press Association 2009