Source: DGNews  |  Posted 2 years ago

NEW YORK -- May 20, 2009 -- The Ministry of Health, Labour and Welfare (MHLW) has approved sorafenib (Nexavar) tablets for the treatment of unresectable hepatocellular carcinoma (HCC).

The decision was based on positive data from the international, phase 3, double-blind, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial that evaluated more than 600 patients who received no prior systemic therapy.

The study found that sorafenib extended overall survival by 44% in patients with HCC versus placebo.

The most common adverse reactions which were considered to be related to sorafenib are fatigue, weight loss, rash/desquamation, hand-foot skin reaction, alopecia, diarrhoea, anorexia, nausea, and abdominal pain

SOURCE: Bayer