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October 2, 2023

Oncoheroes Gains FDA Approval for Pediatric Cancer Drug Trials

In a groundbreaking development for pediatric oncology, Oncoheroes Biosciences, Inc. has received the FDA's green light to proceed with two crucial clinical trials. This milestone opens the door to exploring potential drug treatments for young cancer patients, offering newfound hope in the fight against childhood cancer.

Pediatric Cancer Drug Trials

The U.S. Food and Drug Administration (FDA) recently granted Oncoheroes the green light for two Investigational New Drug (IND) applications submitted in August. These applications sought permission to initiate pediatric clinical drug trials for two compounds in Oncoheroes' portfolio: volasertib and dovitinib. Following a meticulous review, the FDA's approval paves the way for innovative treatment options targeting pediatric cancer.

Volasertib: Volasertib operates as an inhibitor of Polo-like-kinase 1 (PLK1), an enzyme with a known role in various cancer progressions. Oncoheroes acquired this compound from Boehringer Ingelheim, which initially developed it for Acute Myeloid Leukemia. Preclinical data highlights its potential for treating rhabdomyosarcoma and other pediatric cancer indications.

Dovitinib: Dovitinib is a pan-tyrosine kinase inhibitor that targets fibroblast growth factor receptor (FGFR), vascular endothelial growth factor receptor (VEGFR), and other receptor tyrosine kinases (RTKs). Oncoheroes exclusively licensed dovitinib for pediatric use from Allarity Therapeutics in 2022. This drug category shows promise in addressing pediatric bone sarcomas, supported by an exploratory biomarker for identifying potential responders to the treatment.

In conclusion, the FDA's approval marks a pivotal moment in the battle against pediatric cancer. With the green light for pediatric cancer drug trials using volasertib and dovitinib, new hope emerges for children and their families in their fight against this devastating disease. The journey to reshape pediatric oncology continues, and the promise of improved treatments and brighter outcomes is on the horizon.

If you or a family member would like to gather additional information about these upcoming pediatric clinical drug trials please feel free to get in touch with Shreya Prakash, our Patient Navigator with "Direct Connect" by emailing her at or calling/texting 425-436-8688. Alternatively, you can complete our Patient Interest Form, and EBCI will contact you.


Enhancing patient outcomes by expanding FDA-approved treatment modalities and fueling research in the pharma/bio/life sciences, device & diagnostic industries and by closing the existing GAP from initial diagnosis to IMMEDIATE AND EXPANDED ACCESS to specialists, researchers, advanced & innovative treatments, clinical trials and critical care with the ultimate goal of improving patient outcomes through updating and improving WHO & NCCN Guidelines and clinical practices related to Standard of Care for brain cancer patients.

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