Partnering with Regulatory Agencies Worldwide to Accelerate the Delivery of Crucial Medicines to Patients in Need
Aug 01, 2015
On average, it takes 10 years to research and develop a new medicine, such as a new cancer treatment.1 That’s a long time to wait for patients facing a devastating diagnosis like advanced or metastatic cancer for which there is no cure. While clinical research is a careful, scientific process that takes time, on the development side, regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are partnering with pharmaceutical companies to try to speed up the delivery of these vital medicines so that appropriate patients may benefit sooner.
One example is the FDA’s "Breakthrough Therapy" designation. Launched in 2012, this process confirms the FDA’s commitment to expedite the development and review of new medicines for serious conditions. Approximately 90 designations have been granted thus far, with 40% awarded to investigational cancer treatments.2
Novartis is committed to developing medicines to help treat diseases in which there remains significant unmet medical need and has collaborated with the FDA to receive six Breakthrough Therapy designations to date, reinforcing the company’s trajectory as an industry leader in innovating for patients. Two of the six designations received thus far were for lung cancer, the number one cause of cancer deaths worldwide,3 and each of these "breakthrough" therapies target specific biomarkers, or underlying genetic changes that drive the cancer, demonstrating the value these types of therapies bring to the right patients.
"Our Breakthrough Therapy designations in lung cancer underscore not only our dedication to precision oncology, but also our growing commitment to addressing the needs of patients living with this devastating disease," said Alessandro Riva, MD, Global Head of Oncology Development and Medical Affairs, Novartis Oncology. "Novartis is at the forefront of transforming how cancer is managed and treated, and across our portfolio of targeted and immuno-oncology therapies, we will continue to pursue accelerated drug discovery and development for those patients most in need."