NCI Launches Formulary to Advance Cancer Clinical Trials

The National Cancer Institute (NCI) recently created a drug formulary that will allow researchers from NCI-designated Cancer Centers to obtain approved and investigational compounds to use in preclinical and cancer clinical trials.

This novel formulary may result in increasing the availability of cancer treatment options, according to a press release from the National Institutes of Health (NIH).

The NCI Formulary is a collaboration between NCI, a part of the NIH, and pharmaceutical companies, and is an effort that supports Vice President Joe Biden’s Cancer Moonshot, which calls for faster creation of treatment options.

Through the formulary, clinical trials will be expedited by removing the negotiation process required for researchers to access the drugs on their own, according to the NIH. The negotiation process may take up to 18 months in some cases, which can significantly impede research efforts.

“The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said NCI Acting Director Douglas Lowy, MD. “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 new formulary will include 15 targeted drugs from pharmaceutical companies, including Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and Xcovery Holding Company.

“The agreements with these companies demonstrate our shared commitment to expedite cancer clinical trials and improve outcomes for patients,” said James Doroshow, MD, 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.”

Launching the NCI Formulary will create a mediator between researchers and pharmaceutical companies, and streamline processes to ensure timely access to the drugs. Following approval, the researchers will be able to acquire the available agents, and evaluate them in new studies. These drugs can also be used to assess drug combinations that include agents from different companies.

The formulary uses valuable information learned from NCI’s Cancer Therapy Evaluation Program, and the NCI-MATCH trial. The trial explored which targeted drugs are being explored as a monotherapy or combination therapy in patients, according to the press release. Since genomic sequencing data has become very common for choosing a therapy, combinations of targeted treatments have become more popular.

The implementation of the NCI Formulary will complement another NIH public-partnership, called the Partnership to Accelerate Cancer Therapies. Through this partnership, the NIH, FDA, private biopharmaceutical companies, foundations, and cancer advocacy groups will support new research in an effort to advance therapies, according to the press release.

“We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with NCI,” Dr Doroshow concluded. “By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”