NCI Launches Drug Formulary

Through its Cancer Therapy Evaluation Program (CTEP), the NCI has launched a public–private partnership with the pharmaceutical industry. Called the NCI Formulary, it aims to speed access to drugs for preclinical and clinical studies to investigators at NCI-designated cancer centers (https://nciformulary.cancer.gov).

“One of the key things with this partnership is that it will expedite the process by which investigators studying combinations of drugs from different companies acquire those agents,” says James Doroshow, MD, the NCI's deputy director for clinical and translational research. Instead of spending considerable time negotiating with separate companies, researchers can use the formulary as a go-between: CTEP will forward study proposals to the relevant companies, who then decide within 60 days if they will supply the drugs requested.

“Previously, this could take as long as 18 months because of the need to hammer out the terms, such as data rights, in individual agreements with each company,” Doroshow says. With the new formulary, participating companies have agreed to use standard terms negotiated over many years with CTEP, he explains. Approved clinical trials will be conducted using the NCI's established infrastructure, including its systems for reporting clinical data and serious adverse events.

Currently, the formulary comprises 16 drugs from six companies: Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and Xcovery. These include not only approved drugs—the PD-1 inhibitor nivolumab (Opdivo; Bristol-Myers Squibb), for instance, and the PD-L1 inhibitor atezolizumab (Tecentriq; Genentech)—but also experimental agents such as prexasertib (Eli Lilly), which blocks CHK1, and ensartinib (Xcovery), a next-generation ALK inhibitor. (See table on the next page for a full list.)

Doroshow notes that approved studies will be entirely investigator-funded; companies are not required to provide financial support. In terms of expediting agent access, “I don't think this is inconsequential [to companies],” he says. “There's quite a difference between being asked to supply a drug, versus that plus substantial funding.”

The need for institutional funding aside, “at least drug access will now be less of a barrier,” says Stanton Gerson, MD, director of Case Comprehensive Cancer Center in Cleveland, OH. He thinks this “will spawn new drug combinations,” and evaluating these within NCI-designated centers will “encourage the best ideas to move forward on neutral turf.”

Joe Gray, PhD, chair of biomedical engineering at Oregon Health and Science University (OHSU) in Portland, has long advocated for the formulary's launch. Until now, many researchers have found it easier to have third-party chemical suppliers synthesize a given drug rather than obtain it from pharmaceutical companies. However, “the quality control is uneven and you don't always get what you think you're buying,” he says.

At OHSU's Knight Cancer Institute, Gray adds, “we're trying to understand and counteract resistance mechanisms in individual patients. We'll be testing strategies in real time, more or less, so we need quick access to a broad range of compounds. Through the formulary, we'll have assurance that these are of guaranteed quality, not some approximation thereof.”

Negotiations between the NCI and additional companies are ongoing, Doroshow says, and “if this turns out to be a facile way to get drugs and set up trials, I'm sure we'll get even more interest.” He hopes to see the number of participating companies and available agents double by the end of 2017. –Alissa Poh

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