GlaxoSmithKline receives FDA approval for advanced renal cell carcinoma treatment
GlaxoSmithKline has received approval from the US Food and Drug Administration (FDA) for the Votrient (pazopanib) drug. The drug is approved for the treatment of patients with advanced renal cell carcinoma (RCC), a form of kidney cancer. The FDA’s Oncologic Drugs Advisory Committee (ODAC) had earlier voted unanimously in favor of the drug due to encouraging results from the phase III trial.

Safety labeling revision for GlaxoSmithKline’s Tykerb (lapatinib tablets) that includes a boxed warning about the risk of hepatotoxicity has been approved by the U.S. Food and Drug Administration. Hepatotoxicity cases have been reported during clinical trials, some of them being severe. The FDA has noted that the onset of the disease has taken place within a few months from initiation of the therapy. Tests for liver functioning should be taken before starting and during lapatinib treatment, every month. Lapatinib is a kinase inhibitor to be used along with capecitabine in the treatment of advanced breast cancer in patients who did not benefit from a therapy earlier.