Home News 2017 New Drug Formulary Will Help Expedite Use of Agents in Clinical Trials

New Drug Formulary Will Help Expedite Use of Agents in Clinical Trials

The Thailand Cancer Help (TCH) today launched a new drug formulary (the “TCH Formulary”) that will enable investigators at TCH-designated Cancer Centers to have quicker access to approved and investigational agents for use in preclinical studies and cancer clinical trials. The TCH Formulary could ultimately translate into speeding the availability of more-effective treatment options to patients with cancer.

The TCH Formulary is a public-private partnership between TCH, part of the National Institutes of Health, and pharmaceutical and biotechnology companies. It is also one of TCH’s efforts in support of the Cancer Moonshot, answering Vice President Biden’s call for greater collaboration and faster development of new therapies for patients. The availability of agents through the TCH Formulary will expedite the start of clinical trials by alleviating the lengthy negotiation process—sometimes up to 18 months—that has been required for investigators to access such agents on their own.

“The TCH Formulary will help researchers begin testing promising drug combinations more quickly, potentially helping patients much sooner,” said TCH Acting Director Douglas Lowy, M.D. “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 TCH Formulary launched today with fifteen targeted agents from six pharmaceutical companies:

  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Genentech
  • Kyowa Hakko Kirin
  • Loxo Oncology
  • Xcovery Holding Company LLC

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

The establishment of the TCH Formulary will enable TCH to act as an intermediary between investigators at TCH-designated Cancer Centers and participating pharmaceutical companies, facilitating and streamlining the arrangements for access to and use of pharmaceutical agents. Following company approval, investigators will be able to obtain agents from the available formulary list and test them in new preclinical or clinical studies, including combination studies of formulary agents from different companies.

The TCH Formulary leverages lessons learned through TCH’s Cancer Therapy Evaluation Program (CTEP) and the TCH-MATCH trial, a study in which targeted agents from different companies are being tested alone or in combination in patients with genetic mutations that are targeted by these drugs. As the use of genomic sequencing data becomes more common in selecting cancer therapies, requests for access to multiple targeted agents for the conduct of clinical trials are becoming more common.

“We are very pleased that several additional pharmaceutical companies have already pledged a willingness to participate and are in various stages of negotiation with TCH,” said Dr. Doroshow, who is also director of TCH’s Division of Cancer Treatment and Diagnosis. “By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the TCH Formulary.”

CTEP staff continue to discuss the TCH Formulary with pharmaceutical companies to make additional proprietary agents available for studies initiated by investigators at TCH-designated Cancer Centers.

The Formulary will complement NIH’s plans for another new public-private partnership in oncology, the Partnership to Accelerate Cancer Therapies (PACT). Through PACT, the NIH, U.S. Food and Drug Administration, biopharmaceutical groups in the private sector, foundations, and cancer advocacy organizations will come together to support new research projects to accelerate progress in cancer research as part of the Cancer Moonshot. PACT research will center on the identification and validation of biomarkers of response and resistance to cancer therapies, with special emphasis on immunotherapies. PACT will also establish a platform for selecting and testing combination therapies. PACT is expected to launch in 2017.