FDA Approves Votrient® For Treatment Of Patients With Certain Types Of Advanced Soft Tissue Sarcoma

CYP Substrates: Concomitant use of VOTRIENT with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended.

Concomitant use of VOTRIENT and simvastatin increases the risk of ALT elevations and should be undertaken with caution and close monitoring.

Adverse Reactions: The most common adverse reactions (greater than or equal to 20%) in subjects with STS who received VOTRIENT versus placebo were fatigue (65% vs. 48%), diarrhea (59% vs. 15%), nausea (56% vs. 22%), decreased weight (48% vs. 15%), hypertension (42% vs. 6%), decreased appetite (40% vs. 19%), hair color changes (39% vs. 2%), vomiting (33% vs. 11%), tumor pain (29% vs. 21%), dysgeusia (28% vs. 3%), headache (23% vs. 8%), musculoskeletal pain (23% vs. 20%), myalgia (23% vs. 9%), gastrointestinal pain (23% vs. 9%), dyspnea (20% vs 17%).

Laboratory abnormalities occurring in >10% of STS subjects and more commonly (greater than or equal to 5%) in the VOTRIENT arm versus placebo included increases in AST (51% vs. 22%), ALT (46% vs. 18%), glucose (45% vs. 35%), alkaline phosphatase (32% vs. 23%), total bilirubin (29% vs. 7%), and potassium (16% vs. 11%); decreases in sodium (31% vs. 20%) and albumin (34% vs. 21%); and leukopenia (44% vs. 15%), lymphocytopenia (43% vs. 36%), thrombocytopenia (36% vs. 6%), and neutropenia (33% vs. 7%).

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Cautionary statement regarding forward-looking statements Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2011.

 

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