Novartis AG (NYSE:NVS) has just announced that its breast cancer pill, LEE011 has been awarded a breakthrough therapy designation from the U.S. regulators as a first line of treatment for a form of advanced breast cancer. The Food and Drug Administration granted approval for the pill to be used with human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer and letrozole.
The award is a positive indication from the regulators, who view LEE011 as potentially offering an improvement over currently available therapies on at least one clinically significant endpoint. With this designation, the drug will get expedited development and review, so that it is available for patients within the shortest time possible.
The FDA’s decision came after data from Phase III MONALEESA-2 trials, which involved postmenopausal women who had received no prior therapy for their advanced disease, had an improvement in progression free survival for those who were taking the drugs. The full results of this study are to be presented at an upcoming medical congress. This data is expected to form the basis of regulatory discussions in the US, Europe, and other countries for use in this indication. Clinical trials testing the pill were stopped early because of the good results.
Alessandro Riva, the MD, Global Head, Oncology Development and Medical Affairs, Novartis Oncology noted that despite the advancement in breast cancer treatment, about 40,000 people in the United States die annually. He further noted that the designation from the FDA shows the potential that LEE0011 has, and they are looking forward to close collaboration with the FDA and advanced cancer community so that they can provide a treatment option for women living with advanced breast cancer as quickly as possible.