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FDA Approves Remestemcel-L for Pediatric Steroid-Refractory Acute Graft-vs-Host Disease
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The FDA has expanded the approval of methotrexate to include use in pediatric patients with acute lymphoblastic leukemia.

The FDA has granted rare pediatric disease designation to galinpepimut-S for acute myeloid leukemia.

Saro H. Armenian, DO, MPH, discusses treatment advancements that have helped reduce long-term adverse effects for patients in pediatric oncology.

Saro H. Armenian, DO, MPH, discusses the difficulties that patients face when transitioning from pediatric to adult cancer care, highlighting unmet needs.

The FDA has granted rare pediatric disease designation to LP-184 in malignant rhabdoid tumors, rhabdomyosarcoma, and hepatoblastoma.

R. Lor Randall, MD, FACS, discusses the relationship between poverty, race, ethnicity, and survival outcomes in pediatric nonmetastatic osteosarcoma.

Tisagenlecleucel is moving to earlier lines of therapy for pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Priority review was granted to the NDA seeking approval of mirdametinib in patients with neurofibromatosis type 1–associated plexiform neurofibromas.

Opaganib has received orphan drug designation from the FDA for use in patients with neuroblastoma.

The FDA has awarded rare pediatric disease designation and orphan drug designation to INV724 for the treatment of neuroblastoma.

Luis E. Raez, MD, FACP, FCCP, FASCO, discusses the FDA approval of repotrectinib for NTRK-positive advanced solid tumors.

The FDA has approved vorasidenib for grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation.

In case you missed any, below is a recap of every OncLive On Air episode that aired in July 2024.

The FDA has accepted the resubmission of a BLA for remestemcel-L in pediatric steroid-refractory acute graft-vs-host-disease.

The BLA seeking approval for remestemcel-L for children with steroid-refractory acute graft-vs-host-disease has been resubmitted to the FDA.

Daniel M. Halperin, MD, details the FDA approval of lutetium Lu 177 dotatate as well as safety and efficacy data in pediatric and adult patients treated with the agent.

The FDA has granted accelerated approval to selpercatinib for pediatric patients with select RET-altered metastatic thyroid cancers or solid tumors.

Carrie L. Kitko, MD, discusses the use of obecabtagene autoleucel for pediatric patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

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.

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

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

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

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

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













































































