Winners of ESMO 2010

Monday, October 25th, 2010

 

The ESMO meeting is the most important oncology conference in Europe. This year in particular, it included very interesting data that affected the sentiment towards many biotech companies. Here, I intend to focus on what I view as three clear winners from the conference: Seattle Genetics (SGEN), Arqule (ARQL) and Dendreon (DNDN).     

Seattle Genetics

Seattle Genetics is about to conclude the best year in its history, since it was incorporated 13 years ago.  The company’s lead agent, SGN-35 (aka Brentuximab Vedotin), generated astonishing results in two types of blood cancers earlier this year. Based on the results in Hodkin’s Lymphoma, SGN-35’s approval seems inevitable, even though results are not from large randomized studies. Unlike T-DM1’s case, Seattle Genetics negotiated a special protocol assessment (SPA) with the FDA, implying that the trial design and endpoints are acceptable by the FDA.

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Posted in Monocloncal antibodies, kinase inhibitors | 13 Comments »

Immunogen – Another Step towards FDA Approval

Sunday, April 18th, 2010

Earlier this week, Immunogen (IMGN) got closer than ever to having a commercial product in the market. During its quarterly call, Roche removed the regulatory overhang on T-DM1’s near term fate after it disclosed plans to file for T-DM1’s approval already this year. The submission will be based on results from a recently announced phase II trial where T-DM1 demonstrated overwhelming activity in late stage breast cancer patients. Until now, it was unclear whether the FDA would be willing to consider approval based on a single arm phase II trial. Roche’s decision implies the FDA gave its unofficial and non-binding blessing for the accelerated approval.

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Posted in Monocloncal antibodies, solid tumors | 7 Comments »