Tykerb/Herceptin Combination Will Go Before FDA Advisory Panel

FDA’s Oncologic Drugs Advisory Committee will review a combination of GlaxoSmithKline’s Tykerb (lapatinib) with Roche’s Herceptin (trastuzumab) that would offer patients with HER-2 positive metastatic breast cancer a chemo-free option.

FDA’s Oncologic Drugs Advisory Committee will review an application July 24 for use of two targeted agents in combination against metastatic HER-2 positive breast cancer, an area of labeling regulators thus far have not had much chance to consider.

At issue is GlaxoSmithKline PLC’s supplementary marketing application to use its breast cancer drug Tykerb (lapatinib) with Roche’s...

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