Final Perjeta Overall Survival Data Delayed By Its Efficacy
This article was originally published in The Pink Sheet Daily
Overall survival results from the CLEOPATRA study, which produced the progression-free survival data that supported FDA’s decision in June to give Perjeta full approval for use in combination with Herceptin and chemotherapy, were reported at the San Antonio Breast Cancer Symposium Dec. 7.
You may also be interested in...
Despite concerns about accelerated approval on the basis of pathological complete response, which has not yet been correlated with improvements in longer-term outcomes, FDA panelists say the large body of efficacy and safety data supporting Genentech’s pertuzumab makes it worth the regulatory risk.
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.
Roche posted solid 2012 results and development of new cancer drugs continues apace, forecasting further sales and profit gains in 2013 and beyond – as long as government insurers can handle the abundance.