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Positive EMEA opinion for Tykerb


GlaxoSmithKline (GSK) has announced that Tykerb (lapatinib) has received a positive opinion recommending a conditional marketing authorisation from the EMEA.

The drug, in combination with capecitabine, has been indicated for the treatment of women who have advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).

GSK said it is the first oral, small molecule dual-targeted therapy that works by getting inside the cancer cell to inhibit both ErbB1 (EGFR) and ErbB2 (HER2), two receptor proteins which are responsible for tumour growth.

Paolo Paoletti, global head of the Oncology Medicine Development Centre at GSK, said: “This is an extremely significant development for patients and physicians across Europe as lapatinib, in combination with capecitabine, will play a valuable role in treating an especially aggressive form of advanced breast cancer by providing an effective treatment that offers added convenience as an oral therapy.”

Andrew Witty, GSK’s president of pharmaceuticals for Europe, added: “The innovative mechanism of action of lapatinib represents a new way to treat breast cancer patients.

“It is also important to note that this is GSK’s second EMEA positive opinion for a cancer treatment in a matter of months, following the positive opinion and approval of Atriance (nelarabine) in the summer.

“These positive opinions underscore our commitment to develop an industry leading oncology portfolio to address the unmet medical needs of cancer patients, whether they be for highly prevalent or extremely rare forms of the disease.”

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