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 Grants Accelerated Approval to Tovorafenib for Pediatric Relapsed/Refractory BRAF+ Low-Grade Glioma

April 23rd 2024

The FDA granted accelerated approval to tovorafenib for pediatric patients relapsed/refractory low-grade glioma with a BRAF fusion/rearrangement or a BRAF V600 mutation.

FDA Approves Lutetium Lu 177 Dotatate for Pediatric SSTR+ GEP-NETs

April 23rd 2024

The FDA has approved lutetium Lu 177 dotatate for pediatric patients 12 years of age and older with SSTR–positive GEP-NETs.

Functional Precision Medicine Method Aids Treatment Decision-Making in R/R Pediatric Cancers

April 19th 2024

A unique approach combining genomic and sensitivity testing with machine learning was feasible for guiding treatment selection in pediatric cancers.

March Approval Madness: OncLive’s Roundup of FDA Decisions in Oncology

April 13th 2024

In case you missed it, these were the key regulatory decisions made by the FDA in March 2024.

FDA Approves Inotuzumab Ozogamicin for Pediatric CD22+ B-Cell Precursor Acute Lymphoblastic Leukemia

March 6th 2024

The FDA has approved inotuzumab ozogamicin for pediatric patients with relapsed/refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

International Childhood Cancer Day Shines a Spotlight on Challenges in Pediatric Oncology

February 20th 2024

Burton Eliot Appel, MD, discusses the importance of recognizing Childhood Cancer Day in pediatric patients with cancer.

Dr Appel on the Significance of International Childhood Cancer Day

February 15th 2024

Burton Eliot Appel, MD, discusses the significance of International Childhood Cancer Day.

Insights Into Pediatric Oncology on Childhood Cancer Day: Advances, Challenges, and Survivorship

February 15th 2024

Burton Eliot Appel, MD, discusses the landscape of pediatric oncology on International Childhood Cancer Day.

FDA Approves Eflornithine for Adult, Pediatric Patients With High-Risk Neuroblastoma

December 13th 2023

The FDA has approved eflornithine (Iwilfin) as a treatment to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have achieved at least a partial response to prior multi-agent, multimodality therapy including anti-GD2 immunotherapy.

FDA Grants Priority Review to Tovorafenib in Pediatric Relapsed/Progressive Low-Grade Glioma

October 30th 2023

The FDA has granted priority review to a new drug application seeking the approval of tovorafenib monotherapy for the treatment of pediatric patients with relapsed or progressive low-grade glioma.

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.