Breast Cancer Protection Plan In Place, Roche Turns Attention To Hematology
With new drugs at hand to protect its Herceptin breast cancer franchise, Roche announced positive data for its rituximab replacement candidate and other steps in its plan to protect top-seller Rituxan/MabThera.
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Small molecule Bcl-2 inhibitor GDC-0199/ABT-199 demonstrates an 84% overall response rate and a 23% complete response in early study of high risk CLL presented at ASH. However, tumor lysis syndrome caused one sudden death in the trial and is a potential risk that needs to be well-managed going forward. Roche also reports updated results of Gazyva vs. Rituxan in CLL.
Roche execs made surrogate endpoints the theme of the company’s recent late-stage pipeline review, highlighting in particular the possible use of minimal residual disease as a surrogate endpoint in the clinical trials for its hematologic agents.
Sandoz has begun a global Phase III trial with its biosimilar version of Amgen's Enbrel (etanercept), targeting psoriasis rather than the more lucrative indication for rheumatoid arthritis, with the aim of winning quicker regulatory approval which can be built on as it gains insights testing the medicine.