FDA Oncology Announcements

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28 Announcements

FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection

Trial: MK-3475A-D77
Drug: Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA grants accelerated approval to dordaviprone for diffuse midline glioma

Drug: Modeyso (dordaviprone) · AKT1 inhibitor
Condition: CNS

FDA approves belzutifan for pheochromocytoma or paraganglioma

Trial: MK-6482-015
Drug: Welireg (belzutifan) · HIF-2a inhibitor
Conditions: CNSEndocrine

FDA approves vorasidenib for Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Drug: Voranigo (vorasidenib) · IDH inhibitor
Condition: CNS

FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors

Trial: TRIDENT-1
Drug: AUGTYRO (repotrectinib) · ROS1 inhibitor
Condition: Other solid neoplasm

FDA grants accelerated approval to tovorafenib for patients with relapsed or refractory BRAF-altered pediatric low-grade glioma

Trial: FIREFLY-1
Drug: Ojemda (tovorafenib) · BRAF inhibitor
Condition: CNS

FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors

Trials: DPT02, DESTINY-Lung01, DESTINY-CRC02
Drug: Enhertu (fam-trastuzumab deruxtecan-nxki) · Anti-HER2 antibody-drug conjugate
Condition: Other solid neoplasm

FDA approves eflornithine for adult and pediatric patients with high-risk neuroblastoma

Drug: IWILFIN (eflornithine) · Ornithine decarboxylase inhibitor
Condition: CNS

FDA expands pediatric indication for entrectinib and approves new pellet formulation

Trial: STARTRK-NG
Drug: Rozlytrek (entrectinib) · TRK inhibitor
Condition: Other solid neoplasm

FDA approves new and updated indications for temozolomide under Project Renewal

Drug: Temodar (temozolomide) · Triazene
Condition: CNS

FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: CNS

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors

Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Other solid neoplasm

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

Trial: SIOPEL6
Drug: Pedmark (sodium thiosulfate)
Condition: Other solid neoplasm

FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation

Drugs: Tafinlar (dabrafenib) · BRAF inhibitor, Mekinist (trametinib) · MEK inhibitor
Condition: Other solid neoplasm

FDA grants accelerated approval to dostarlimab-gxly for dMMR advanced solid tumors

Drug: Jemperli (dostarlimab-gxly) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

Drug: DANYELZA (naxitamab) · Anti-GD2 antibody
Condition: CNS

FDA grants accelerated approval to naxitamab for high-risk neuroblastoma in bone or bone marrow

Drug: DANYELZA (naxitamab) · Anti-GD2 antibody
Condition: CNS

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

FDA Approves Companion Diagnostic to identify NTRK fusions in solid tumors for Vitrakvi

Trials: SCOUT, NAVIGATE
Condition: Other solid neoplasm

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Trial: KEYNOTE 158
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Other solid neoplasm

FDA approves larotrectinib for solid tumors with NTRK gene fusions

Drug: VITRAKVI (larotrectinib) · TRK inhibitor
Condition: Other solid neoplasm

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

Trial: EXIST-3
Drugs: Afinitor Disperz (everolimus tablets for oral suspension) · MTOR inhibitor, Afinitor Disperz (oral suspension)
Condition: CNS

Aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas

Drug: Gleolan (aminolevulinic acid hydrochloride)
Condition: CNS

Everolimus for Tuberous Sclerosis Complex (TSC)

Drug: Afinitor Disperz (everolimus tablets for oral suspension) · MTOR inhibitor
Condition: CNS

Everolimus (Accelerated Approval)

Drug: Afinitor (everolimus) · MTOR inhibitor
Condition: CNS

Bevacizumab Injection

Drug: Avastin (bevacizumab) · Anti-VEGFR antibody
Condition: CNS

Iobenguane I 123

Drug: AdreView (iobenguane I 123)
Conditions: CNSEndocrine