FDA panel supports the company's votrient, a soft tissue sarcoma drug

Source: China Council for the promotion of drugs (2012-03-22) received a good news from Glaxo company FDA cancer drug advisory committee voted (11-2) to approve its drug votrient for the treatment of malignant soft tissue sarcoma for patients who have received chemotherapy In 2009, the FDA approved votrient for the treatment of malignant renal cell carcinoma However, the panel did not bring good news to Merck and ariad Merck and ariad hope the panel will recommend ridafoolimus as a maintenance drug for soft tissue sarcoma to FDA But the panel voted 13-1 against the use A jubilant GlaxoSmithKline praised the panel's overwhelming vote "The treatment options for patients with malignant soft tissue sarcoma are limited, so we are pleased that the expert committee appreciates votrient's clinical data." Said Rafael Amado, senior vice president of cancer at GlaxoSmithKline According to the results of the study, the median progression free survival of votrient was 4.6 months, 3.1 months longer than placebo "It's a small step, but it's a small step in the field of no treatment." , during the panel meeting, panel member Lee Hellman said Bloomberg cited The panel found that Merck and ariad had no similar advantages In fact, the median progression free survival was 17.7 weeks in patients taking ridafoolimus and 14.6 weeks in the placebo group, Dow Jones noted Given the small difference in survival and the potential risk of adverse reactions such as infection, rash and, in some cases, renal impairment, the panel decided not to support the approval of the drug Original link: http://