http://www.pharmaphorum.com/forums/ Bringing Healthcare Together en Tue, 07 Sep 2010 15:29:13 +0000 http://www.pharmaphorum.com/forums/topic/cell-therapeutics-lymphoma-drug-questioned-by-fda#post-516 Mon, 08 Feb 2010 17:29:22 +0000 Paul 516@http://www.pharmaphorum.com/forums/ <p>Reuters reports today on new data just released that questions the side effects profile of the drug Pixuvri, a lymphoma treatment developed by Cell Therapeutics.</p> <p>The US Food and Drug Administration (FDA) raised concerns about “substantial hematologic and cardiac toxicity” for Pixuvri (pixantrone), in addition to questioning the efficacy conclusion of the trial data. Cell Therapeutics has filed the drug for the treatment of non-Hodgkin’s lymphoma following the failure of existing therapies, but this new information raises the question of whether it can reach the market. Reuters notes that the FDA has highlighted that the pivotal clinical study enrolled only 50% of the original target patients.</p> <p>An advisory panel meeting on Wednesday will discuss the pixantrone data, but Cell Therapeutics believes the drug has “manageable toxicities”.</p> <p>Ref: Reuters<br /> <a href="http://www.reuters.com/article/idUSN0515749720100208" target="_blank">http://www.reuters.c...dUSN0515749720100208</a></p> <p>Ref: Biospace<br /> <a href="http://www.biospace.com/news_story.aspx?NewsEntityId=170070&amp;Source=TopBreaking" target="_blank">http://www.biospace....p;Source=TopBreaking</a></p> <p>Trouble ahead for Pixuvri? </p>