CHMP removes uncertainty over Tyverb, recommending approval; views other drugs
At its late April meeting, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a revised positive opinion for UK drug major GlaxoSmithKline's Tyverb (lapatinib), recommending the oral breast cancer drug for approval after considering safety data on liver enzyme elevations that emerged earlier this year (Marketletter March 31).
Final authorization for the dual ErbB1 and ErbB2 inhibitor, which analysts believe will reach blockbuster status, had been expected by March 8, after the European Commission gave the drug conditional clearance late last year (Marketletter December 24, 2007).
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