On January 11, 2017, the National Cancer Institute (NCI) unveiled a new formulary, the NCI Formulary. This will enable investigators at NCI-designated Cancer Centers to have quicker access to approved and investigational agents, for use in preclinical studies and cancer clinical trials1. Accessibility will be increased because the existence of the NCI Formulary will shorten the negotiation process which was required for clinical investigators to access the agents on their own. Prior to the launch of the NCI Formulary, this negotiation process could sometimes take up to eighteen months1. The NCI Formulary represents a public-private partnership between the NCI and pharmaceutical and biotechnology companies2. The partnership will provide academic investigators with rapid access to agents or combinations of agents, particularly for use in clinical trials focused on agents targeting molecular pathways, from multiple collaborating pharmaceutical companies2. The requests for and access to multiple targeted agents for the conduct of clinical research trials are becoming more common as genomic sequencing data become mainstream in cancer therapy2.

The NCI Formulary, which launched with fifteen targeted agents from six pharmaceutical companies, will enable NCI to act as an intermediary, between clinical investigators at NCI-designated Cancer Centers and the pharmaceutical companies1. As an intermediary, the NCI will streamline the processes for access to and use of the pharmaceutical agents1. James Doroshow, M.D., NCI’s Deputy Director for Clinical and Translational Research, expects to double the number of partnerships and the number of drugs available in the NCI Formulary by the end of 20171. The pharmaceutical companies which are involved in the launch of the NCI Formulary are, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology and Xcovery Holding Company LLC2.

 

References

  1. National Cancer Institute. (2017, January). NCI Formulary: A Public-Private Partnership. Retrieved January 13, 2017, from NCI Formulary: https://nciformulary.cancer.gov/
  2. National Institutues of Health. (2017, January 11). New Drug Formulary Will Help Expedite Use of Agents in Clinical Trials. Retrieved January 13, 2017, from National Institutes of Health – News Releases: https://www.nih.gov/news-events/news-releases/new-drug-formulary-will-help-expedite-use-agents-clinical-trials