The NCI Formulary is a public-private partnership between NCI, part of the National Institutes of Health, and pharmaceutical and biotechnology companies. The availability of agents through the NCI Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process—sometimes up to 18 months—that has been required for investigators to access such agents on their own.

 

“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Dr. Douglas Lowy. “Rather than spending time negotiating agreements, investigators will be able to focus on the important research that can ultimately lead to improved cancer care.”

 

The NCI Formulary launched with 15 targeted agents from six pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Co., Genentech, Kyowa Hakko Kirin, Loxo Oncology and Xcovery Holding Company LLC.

 

“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” said James Dr. Doroshow, NCI deputy director for clinical and translational research. “It represents a new drug development paradigm that will enhance the efficiency with which new treatments are discovered.”

 

The establishment of the NCI Formulary will enable NCI to act as an intermediary between investigators at NCI-designated Cancer Centers and participating pharmaceutical companies, facilitating and streamlining the arrangements for access to and use of pharmaceutical agents. Following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies, including combination studies of formulary agents from different companies.