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NCI launches program to expedite drug research

Vials of injectable drugs
Photo by Bill Branson

The National Cancer Institute (NCI) has launched a new drug formulary designed to provide investigators at NCI-designated cancer centers with quicker access to approved and investigational agents for use in preclinical studies and clinical trials.

The formulary will enable NCI to act as an intermediary between investigators and participating pharmaceutical companies, facilitating the arrangements for access to and use of pharmaceutical agents.

Following company approval, investigators will be able to obtain agents from the formulary and test them in preclinical or clinical studies, including studies combining formulary agents from different companies.

The NCI says having agents available through the 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 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 NCI Formulary includes 15 targeted agents:

  • Alectinib (ALK inhibitor, tyrosine kinase inhibitor)
  • Atezolizumab (PD-L1 blocking monoclonal antibody)
  • Bevacizumab (anti-angiogenesis inhibitor, monoclonal antibody)
  • Cobimetinib (MEK1/2 inhibitor)
  • Ensartinib (ALK inhibitor)
  • Ipilimumab (anti-CTLA-4 monoclonal antibody)
  • Larotrectinib (tyrosine kinase inhibitor)
  • LY3039478 (Notch inhibitor)
  • Nivolumab (PD-1 blocking monoclonal antibody)
  • Obinutuzumab (anti-CD20 monoclonal antibody)
  • Pertuzumab (anti-HER2 monoclonal antibody)
  • Prexasertib (checkpoint kinase 1 inhibitor)
  • Trastuzumab (anti-HER2 monoclonal antibody)
  • Vemurafenib (BRAF mutant v600 inhibitor)
  • Vismodegib (Hedgehog inhibitor)

The agents are products of 6 different pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and 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, MD, NCI deputy director for clinical and translational research.

“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. By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”

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Vials of injectable drugs
Photo by Bill Branson

The National Cancer Institute (NCI) has launched a new drug formulary designed to provide investigators at NCI-designated cancer centers with quicker access to approved and investigational agents for use in preclinical studies and clinical trials.

The formulary will enable NCI to act as an intermediary between investigators and participating pharmaceutical companies, facilitating the arrangements for access to and use of pharmaceutical agents.

Following company approval, investigators will be able to obtain agents from the formulary and test them in preclinical or clinical studies, including studies combining formulary agents from different companies.

The NCI says having agents available through the 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 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 NCI Formulary includes 15 targeted agents:

  • Alectinib (ALK inhibitor, tyrosine kinase inhibitor)
  • Atezolizumab (PD-L1 blocking monoclonal antibody)
  • Bevacizumab (anti-angiogenesis inhibitor, monoclonal antibody)
  • Cobimetinib (MEK1/2 inhibitor)
  • Ensartinib (ALK inhibitor)
  • Ipilimumab (anti-CTLA-4 monoclonal antibody)
  • Larotrectinib (tyrosine kinase inhibitor)
  • LY3039478 (Notch inhibitor)
  • Nivolumab (PD-1 blocking monoclonal antibody)
  • Obinutuzumab (anti-CD20 monoclonal antibody)
  • Pertuzumab (anti-HER2 monoclonal antibody)
  • Prexasertib (checkpoint kinase 1 inhibitor)
  • Trastuzumab (anti-HER2 monoclonal antibody)
  • Vemurafenib (BRAF mutant v600 inhibitor)
  • Vismodegib (Hedgehog inhibitor)

The agents are products of 6 different pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and 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, MD, NCI deputy director for clinical and translational research.

“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. By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”

Vials of injectable drugs
Photo by Bill Branson

The National Cancer Institute (NCI) has launched a new drug formulary designed to provide investigators at NCI-designated cancer centers with quicker access to approved and investigational agents for use in preclinical studies and clinical trials.

The formulary will enable NCI to act as an intermediary between investigators and participating pharmaceutical companies, facilitating the arrangements for access to and use of pharmaceutical agents.

Following company approval, investigators will be able to obtain agents from the formulary and test them in preclinical or clinical studies, including studies combining formulary agents from different companies.

The NCI says having agents available through the 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 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 NCI Formulary includes 15 targeted agents:

  • Alectinib (ALK inhibitor, tyrosine kinase inhibitor)
  • Atezolizumab (PD-L1 blocking monoclonal antibody)
  • Bevacizumab (anti-angiogenesis inhibitor, monoclonal antibody)
  • Cobimetinib (MEK1/2 inhibitor)
  • Ensartinib (ALK inhibitor)
  • Ipilimumab (anti-CTLA-4 monoclonal antibody)
  • Larotrectinib (tyrosine kinase inhibitor)
  • LY3039478 (Notch inhibitor)
  • Nivolumab (PD-1 blocking monoclonal antibody)
  • Obinutuzumab (anti-CD20 monoclonal antibody)
  • Pertuzumab (anti-HER2 monoclonal antibody)
  • Prexasertib (checkpoint kinase 1 inhibitor)
  • Trastuzumab (anti-HER2 monoclonal antibody)
  • Vemurafenib (BRAF mutant v600 inhibitor)
  • Vismodegib (Hedgehog inhibitor)

The agents are products of 6 different pharmaceutical companies: Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Kyowa Hakko Kirin, Loxo Oncology, and 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, MD, NCI deputy director for clinical and translational research.

“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. By the end of 2017, we expect to have doubled the number of partnerships and drugs available in the NCI Formulary.”

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