Regulatory Focus™ > News Articles > NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

Posted 11 January 2017 | By Michael Mezher 

NCI Launches Formulary to Speed Availability of Investigational Cancer Drugs

The National Cancer Institute (NCI) on Wednesday launched a new effort under the cancer "Moonshot" initiative to speed access to approved and investigational drugs for use in preclinical and clinical cancer studies.

The effort, referred to as the NCI Formulary, is intended to streamline the negotiation process between investigators at NCI-designated cancer centers and participating pharmaceutical companies.

"As genomic sequencing data become mainstream in cancer therapy, requests for and access to multiple targeted agents for the conduct of clinical research studies are becoming more common," NCI writes.

According to NCI, the current negotiation process for these agents can take up to 18 months, which drastically delays the start of research into new drug combinations.

"The NCI Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner," said NCI Acting Director 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."

Specifically, NCI says its Cancer Therapy Evaluation Program (CTEP) will act as an intermediary between investigators and participating drugmakers to negotiate agreements to allow the use of specific agents in NCI-supported studies, including preclinical and clinical studies conducted under an investigational new drug (IND) application.

To ensure that the process of procuring the drugs happens quickly, participating companies are required to conduct a scientific review of proposals for agents listed in the formulary within 60 days of receiving them from CTEP.

Presently, six drugmakers, Bristol-Myers Squibb, Eli Lilly, Genentech, Kyowa Hakko Kirin, Loxo Oncology and Xcovery Holding Company, have agreed to participate in the formulary, making a total of fifteen chemical entities available.

NCI Formulary: Initial Agents Available
AlectinibGenentechAKL inhibitor, tyrosine kinase inhibitor
AtezolizumabGenentechPD-L1 blocking monoclonal antibody
BevacizumabGenentechAnti-angiogenesis inhibitor, monoclonal antibody
CobimetinibGenentechMEK1/2 inhibitor
EnsartinibXcovery Holding CompanyALK inhibitor
IpilimumabBristol-Myers SquibbAnti-CTLA-4 monoclonal antibody
LarotrectinibLoxo OncologyTyrosine kinase inhibitor
LY3039478Eli LillyNotch inhibitor
NivolumabBristol-Myers SquibbPD-1 blocking monoclonal antibody
ObinutuzumabGenentechAnti-CD20 monoclonal antibody
PertuzumabGenentechAnti-HER2 monoclonal antibody
PrexasertibEli LillyCheckpoint kinase 1 inhibitor
TrastuzumabGenentechAnti-HER2 monoclonal antibody
VemurafenibGenentechBRAF mutant v600 inhibitor
VismodegibGenentechHedgehog inhibitor

James Doroshow, NCI deputy director for clinical and translational research, says that NCI expects the number of drugs available through the formulary to double by the end of 2017.

NIH Press Release

NIH Formulary


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