Pass/Fail Grades from the Clinic

 Let's look at drug performance in the clinic today to see which pass and which fail in their bid for approval as reported in GEN.

Pfizer's Sutent for liver cancer - FAIL

OSI's Tarceva for maintenance of NSCLC patients - PASS by FDA

GSK's Duodart for BPH - PASS by European regulatory clearance

Novartis' Joulferon (albinterferon alfa-2b) for chronic HCV - FAIL after EU feedback and Novartis pulls MAA.

Cell Therapeutics Pixuvri for treatment refractory NHL - INCOMPLETE by FDA and more clinical data needed

Merck Serono's Erbitux for 1st-line treatment of colorectal cancer - PASS by Japanese regulators.

Posted by Bruce Lehr April 23rd 2010.

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[Bruce Lehr]

Pharmaceutical Business Review reports on EU approval for Tarceva as a maintenance therapy for patients with non-small cell lung cancer (NSCLC).
http://regulatoryaffairs.pharmaceutical-business-review.com/news/roche_gets_ec_approval_for_tarceva_100429/