publication date: Jun. 26, 2020

In Brief

Kids v Cancer urges Congress to permanently reauthorize pediatric voucher program

Kids v Cancer is urging Congress to pass the Creating Hope Reauthorization Act (S. 4010), which would permanently reauthorize the pediatric voucher program.

The pediatric priority review voucher program encourages the development of new drugs for seriously ill children, including children with cancer, by providing a voucher to pharmaceutical companies which develop such drugs. Vouchers can be used to expedite FDA approval for any other future drug, which allows those future drugs to reach markets faster.

The pediatric voucher program will sunset if Congress does not approve the act by September 30, “ending a critical incentive program for the development of drugs for kids with life threatening illnesses,” Nancy Goodman, executive director of Kids v Cancer, said in a statement.

Bob Casey (D-PA) and Susan Collins (R-ME) introduced the bill to the Senate. G.K. Butterfield and Michael McCaul introduced the Creating Hope Reauthorization Act in the House in September 2019 (H.R. 4439).

The rare pediatric priority review voucher program has resulted in 22 novel therapies for seriously ill children, and in over one billion dollars of incentives for companies to develop rare pediatric disease drugs with no cost to consumers or taxpayers, Goodman said.

“The Children’s Oncology Group is highly supportive of the impact that the Creating Hope Reauthorization Act brings to the care of children with cancer,” Doug Hawkins, chair of the Children’s Oncology Group, said in a statement. “There remains a significant need to focus effort on making better medicines more available for all children and the pediatric voucher program plays an instrumental role in this effort.”

 

UAMS Winthrop P. Rockefeller Cancer Institute joins Kiyatec clinical study

Winthrop P. Rockefeller Cancer Institute at the University of Arkansas for Medical Sciences has joined the 3D-PREDICT clinical study, by Kiyatec Inc., to validate the company’s test as a patient-specific predictor of response to recommended drug therapies for patients with ovarian cancer.

“We developed our investigational ovarian cancer drug response profile to help optimize therapeutic decision-making over the course of the disease,” Matthew Gevaert, CEO of Kiyatec, said in a statement.

3D-PREDICT is a prospective, open-label, non-interventional study to validate Kiyatec’s ovarian cancer drug response profile, which leverages the company’s ex vivo 3D cell culture technology platform to assess pre-treatment, patient-specific response to a panel of 11 drugs most commonly used to treat patients with newly diagnosed or recurrent ovarian cancer.

Kiyatec uses its ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors.

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