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NCI Formulary designed to expedite use of cancer therapies in clinical trials
The NCI today launched a new drug formulary designed to enable investigators at NCI–designated cancer centers to have quicker access to approved and investigational agents for use in preclinical studies and clinical trials.
“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” Douglas Lowy, MD, acting director of NCI, said in a press release. “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 — a public–private partnership between NCI and pharmaceutical and biotechnology companies — is intended to foster greater collaboration and contribute to faster development of new therapies for patients, two key goals outlined in the national cancer moonshot initiative.
The formulary will begin with a focus on 15 targeted agents from six pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology and Xcovery Holding Company LLC.
The NCI will act as an intermediary and, following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies. These investigations will include combination studies of formulary agents from different companies.
NCI expects to double the number of partnerships and drugs available in the NCI Formulary by the end of this year.
“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” James Doroshow, MD, deputy director for clinical and translational research at NCI, said in the release. “It represents a new drug development paradigm that will enhance the efficiency with which new treatments are discovered.”
The formulary also is intended to complement the Partnership to Accelerate Cancer Therapies (PACT), a public–private partnership between NIH, FDA, biopharmaceutical groups in the private sector, foundations and cancer advocacy organizations.
PACT, expected to launch this year, will focus on the identification and validation of biomarkers of response and resistance to cancer therapies — with an emphasis on immunotherapies — and establish a platform for selecting and testing combination therapies.