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The 2015 Oncology Drug Pipeline: Innovation Drives the Race to Cure Cancer.

“Innovation drives progress,” suggests the US Food and Drug Administration (FDA) in its report on the 41 new molecular entities and new biologic pharmaceuticals that were approved in 2014.1 This perspective is echoed by the FDA's Center for Drug Evaluation and Research (CDER) as the rationale for its support for innovation in the pharmaceutical industry. The CDER states, “The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public. For this reason, CDER supports innovation and plays a key role in helping to advance new drug development.”1 
 
More recently, in a provocative article published in this journal and titled “Breaking the Bank: Three Financing Models for Addressing the Drug Innovation Cost Crisis,” Kleinke and McGee argue that drug innovation is key to medical advances, especially in deadly diseases such as cancer: to ensure continuing innovation in drug therapies, what is needed is not to halt funding innovation but rather to find a new way to pay for drugs. “Innovative new treatments designed to address serious diseases in targeted patient populations represent the future of medicine. Traditional payment methodologies need to change to keep pace with medical innovation,” Kleinke and McGee propose, offering 3 models for consideration that will help pay for drugs in a novel way and allow drug innovation to continue in its path.2 
 
Reflecting on oncology drugs in its 2014 report, the IMS Institute for Healthcare Informatics (henceforth, IMS) highlighted innovation as a key feature in the oncology pipeline. According to that report, “Developers have brought innovation across cancer types and therapeutic approaches, including preventive vaccines. Pharmaceutical company investments remain high and cancer therapies account for more than 30% of all preclinical and phase 1 clinical development, with 21 new molecular entities being launched and reaching patients in the last two years alone. These new medicines have increased the complexity of treating cancer, leading to more combination therapies and additional lines of therapy.”3