Pediatric Oncology | Specialty

The OncLive Pediatric Oncology condition center page is a comprehensive resource for clinical news and expert insights on various types of cancers in pediatric patients, including acute lymphoblastic leukemia, acute myeloid leukemia, brain cancers, sarcomas, and more. This page features news articles, interviews in written and video format, and podcasts that focus on unmet needs, treatment advances, and ongoing research in childhood and adolescent and young adult cancers.

FDA Expands Entrectinib Indication in Pediatric Patients With NTRK+ Solid Tumors

October 20th 2023

The FDA has granted accelerated approval to entrectinib (Rozlytrek) for pediatric patients aged older than 1 month with solid tumors that harbor a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and have progressed after treatment or have no satisfactory standard therapy options.

FDA Approves Adjuvant Nivolumab for Completely Resected Stage IIB/C Melanoma

October 14th 2023

The FDA has approved nivolumab (Opdivo) for the adjuvant treatment of adult and pediatric patients 12 years of age and older with completely resected stage IIB or IIC melanoma.

FDA Panel Votes Sufficient Evidence Available to Support EFS Benefit of Eflornithine in Pediatric High-Risk Neuroblastoma

October 6th 2023

In a 14-to-6 vote, the FDA’s Oncologic Drugs Advisory Committee voted sufficient evidence has been provided to demonstrate the event-free survival benefit of eflornithine to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma.

FDA Approves Bosutinib for Pediatric Ph+ CP-CML

September 27th 2023

The FDA has approved bosutinib (Bosulif) for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome–positive, chronic-phase chronic myelogenous leukemia that is newly diagnosed or resistant or intolerant to prior therapy.

European Commission Approves Enrylaze for ALL and Lymphoblastic Lymphoma

September 22nd 2023

The European Commission has granted marketing authorization for Enrylaze for use as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month and older who developed hypersensitivity or silent inactivation to E. coli–derived asparaginase.

FDA Approval Sought for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma

September 11th 2023

A rolling new drug application seeking the approval of tovorafenib monotherapy for the treatment of patients with relapsed or progressive pediatric low-grade glioma has been submitted to the FDA.

FDA Places Clinical Hold on Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML

August 14th 2023

The FDA has placed a clinical hold on the phase 1 PLAT-08 trial evaluating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia.

Herrera Spotlights Key Research Across Hematologic Malignancies From the 2023 ASCO Annual Meeting

August 1st 2023

Alex Herrera, MD, discussed key data from the SWOG S1826 trial and other important research in hematologic malignancies presented at the 2023 ASCO Annual Meeting.

JZP458 Receives CHMP Recommendation for Approval in ALL, Lymphoblastic Lymphoma

July 21st 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of JZP458 for use in combination with multi-agent chemotherapy for the treatment of adult and pediatric patients 1 month and older with acute lymphoblastic leukemia and lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to Escherichia coli–derived asparaginase.

Phase 1 Trial of SC-DARIC33 in Pediatric R/R CD33+ AML on Hold After Serious Grade 5 AE

June 14th 2023

The phase 1 PLAT-08 trial investigating SC-DARIC33 in pediatric and young-adult patients with relapsed/refractory CD33-positive acute myeloid leukemia has been paused following the report of a grade 5 serious adverse effect.

GD2-CART01 Elicits Clinical Activity, Tolerability in Pediatric R/R Neuroblastoma

May 8th 2023

The investigational CAR T-cell therapy GD2-CART01 showed preliminary antitumor activity and safety in pediatric patients with relapsed or refractory high-risk neuroblastoma, according to data from a phase 1/2 trial.

Molecular Analysis Needed to Guide Further Study of Olaparib Plus Ceralasertib in Pediatric Advanced Cancers

April 18th 2023

The combination of PARP and ATR inhibition with olaparib and ceralasertib was tolerable but showed limited efficacy in pediatric patients with advanced malignancies harboring DNA replication stress and DNA repair deficiencies, according to findings from arm N of the phase 1/2 AcSé-ESMART trial.

Sodium Thiosulfate Receives Recommendation for European Approval for Cisplatin-Induced Ototoxicity in Pediatric Patients

April 3rd 2023

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of sodium thiosulfate injection for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localized, nonmetastatic solid tumors.

FDA Grants Full Approval to Pembrolizumab for Select Patients With MSI-H or dMMR Solid Tumors

March 29th 2023

The FDA has granted full approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options.

Multiple Factors Need to Be Addressed to Improve Late Mortality for Survivors of Childhood Cancer

March 24th 2023

Matthew J. Ehrhardt, MD, MS, discusses the importance of taking a multifactorial approach to improve long-term outcomes for survivors of childhood cancer, and expands on the findings from the study of the factors associated with risk of late mortality.

Disadvantaged Neighborhoods, Modifiable Chronic Health Conditions Are Associated With Late Deaths in Survivors of Childhood Cancer

March 22nd 2023

Living in a socioeconomically disadvantaged neighborhood or living with modifiable chronic health conditions were associated with an increased risk for death 5 years of more following diagnosis among survivors of childhood cancer, according to findings from a cohort study.

FDA Approves Dabrafenib Plus Trametinib for Pediatric Patients With BRAF V600E–Mutated Low-Grade Glioma

March 16th 2023

The FDA has approved dabrafenib with trametinib for the treatment of pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation who require systemic therapy.

NCCN Recommends Sodium Thiosulfate to Reduce the Risk for Cisplatin-Induced Hearing Loss in Pediatric Patients

January 25th 2023

Fennec Pharmaceuticals announced an update to the National Comprehensive Cancer Network’s practice guidelines for Adolescent and Young Adult Oncology, calling for the use of sodium thiosulfate injection to reduce the risk for ototoxicity in pediatric patients receiving cisplatin.

FDA Approves Brentuximab Vedotin for Pediatric Patients With Previously Untreated, High-risk Hodgkin Lymphoma

November 10th 2022

The FDA has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma.

FDA Grants Orphan Drug Designation to ET140203 for Hepatoblastoma

October 17th 2022

The FDA has granted an orphan drug designation to ET140203 for the treatment of patients with hepatoblastoma.