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An Unresolved Drama

Although cancer in children is considered rare, it is the leading cause of death by disease among children in USA.

Because One Is Too Many

Despite major treatment advances in recent decades, one in five children with cancer in the US will still not survive.

The Cost Of Surviving

More than 73% will have chronic health problems as a consequence of the treatments they receive.

A Worldwide Problem

Childhood cancer does not discriminate. It is estimated that 80% of children diagnosed with cancer reside in developing countries.

The causes of most childhood cancers are still not known

Only a small minority of pediatric cancers in children are the result of inherited genetic predisposition. More than 90% of cases are the result of new gene mutations.

However, unlike many cancers in adults, gene mutations in childhood cancers are not strongly linked to life style or environmental factors.

**YEARS LOST**

When a child dies of cancer there are 70 potential life years lost on average compared to 15 potential life years lost for adults.

More than 95% of childhood cancer survivors will have significant health related issues by the time they are 45 years of age

Emotional

Changes in mood or behavior, depression, anxiety, social isolation, post traumatic stress disorder, and fear of recurrence

Physical

Hearing/vision loss, damage to endocrine system, dental problems, organ damage, musculoskeletal development disorders, secondary cancers, infertility

Neurocognitive

Changes in attention span, concentration and comprehension, learning disabilities and memory problems, and executive functioning

When a child is diagnosed with cancer, it affects every family member and nearly every aspect of the family’s life

The average family spends 40+ hours per week caring for their child while they are in active treatment

Parents must take time off from work, or in many cases leave their job to care for their child

The diagnosis of a child with cancer often times has a significant negative financial impact upon the family

Siblings of children with cancer are at risk for emotional and behavioral difficulties, such as anxiety, depression, and post traumatic stress disorder

Families often feel that only those who have lived through a similar experience can truly understand the difficulty of the journey

Existing resources are only available during treatment or follow-up visits and well-intentioned support initiatives by outside organizations are often temporary and insufficient

LACK OF RESOURCES

Unfortunately, financial investment for the development of pediatric cancer-specific drugs remains dismal, with only six pediatric-specific drugs approved in the last 20 years versus more than 200 for adults.

The development of pediatric cancer drugs faces several challenges

Twelve types and multiple subtypes

Low incidence rates

Access to expert researchers

Need of pediatric formulations

For several types of pediatric cancers we have not seen any substantial improvement in cure rates over the past few decades and too many children and adolescents still face a very grim prognosis.

However, the current regulatory landscape supports the development of new therapies for children with cancer:

The Orphan Drug Designation Program in the US provides important financial incentives to encourage companies to develop drugs and biologics for rare diseases

The Pediatric Research Exclusivity Act (PREA) provides an additional six months of patent protection for a drug, if a manufacturer also conducts studies of the effect of the drug on children
The Research to Accelerate Cures and Equity (RACE) for Children Act: a major update to PREA requiring companies developing cancer drugs do studies of their drugs in children
The Creating Hope Act, a significant market incentive for the development of drugs for rare pediatric diseases through the establishment of a Priority Review Voucher (PRV)
Market exclusivity is an orphan incentive awarded by the European Commission to a specific clinical indication with an orphan designation that confers ten years' market exclusivity for the particular indication. This period of protection is extended by two years for medicines that also have complied with an agreed pediatric investigation plan granted at the time of review of the orphan medicine designation.

Despite the challenges, and thanks to the global momentum around rare diseases and pediatric indications, Oncoheroes emerges with an unprecedented combination of ingredients for success in pediatric oncology.

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