Lopez Lens: Children’s Cancer Research

Marile Lopez is part of an advocacy group mandating that cancer therapies for adults also be studied in children.

September is Childhood Cancer Awareness Month, a time when we celebrate the advances in childhood cancer treatment and care. And this year, we have even more reason to be hopeful and to fight harder: A new law has passed that medical professionals say could win the battle for countless children. It’s an FDA mandate that states all new cancer therapies for adults must also be studied in children.

This is a law that was enacted three years ago, when I personally went to Washington, DC with my husband Jorge Luis Lopez and we advocated for new treatments and cures on behalf of children battling cancer.  We were among the many children’s health advocates, volunteers, patients and their families on Capitol Hill seeking a new legislation.  Just two weeks ago, on August 18, 2020 amidst the COVID-19 and all that is happening in our world, the bi-partisan Research to Accelerate Cures and Equity (RACE) For Children Act-was implemented

It’s my blessing of five healthy children that has inspired my husband and I to work tirelessly with the American Cancer Society, Nicklaus Children’s Hospital Foundation and St. Jude Children’s Research Hospital.

Elizabeth Fox, MD

I sat down with Elizabeth Fox, MD SR Vice-President of Clinical Trials at St. Jude’s Children’s Research Hospital to discuss how this new law will affect the life of children with cancer, the effects of the new clinical trials that now children will be able to participate in and how to better understand what lies ahead.

Marile Lopez: What will these laws do immediately?
Elizabeth Fox, MD: The RACE for Children Act amends the Pediatric Research Equity Act (PREA) to require evaluation of new molecularly targeted anti-cancer drugs in children with cancer if the molecular target is relevant to the growth or progression of cancer.

After Aug. 18, 2020, applications for anti-cancer drugs will no longer be based on indication such as lung cancer or breast cancer, rather the application for approval by the FDA will be based on the how the drug works, that is, the molecular mechanism of action of the drug. It eliminates a prior loop-hole that exempted testing a drug if the drug was being developed for treatment of a type of cancer, such as lung cancer or breast cancer, that do not occur in children.

ML: Why is there controversy?
EF: Earlier laboratory testing of new drug using pediatric cancer models will be critical. It is unclear how this will be accomplished or if the models will predict if the drug will be effective in children.

ML: What is the long-term effect?
EF:  The hope is to identify new therapies that cure cancer in children with fewer short term and long-term side effects.

ML: What does the community say?
EF: The RACE for Children act dramatically alter the landscape for pediatric cancer drug development by ensuring that new drugs are evaluated in children. It will not solve all the obstacles to pediatric cancer drug development, but it is an important advance for children with cancer. We recognize this will require global collaborations. There is much work to be done, but this month’s achievement of the full implementation of the RACE Act is something we all can celebrate-this is a victory for all children.

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