FDA Oncology Announcements

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37 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 approves belzutifan for pheochromocytoma or paraganglioma

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

FDA approves cabozantinib for adults and pediatric patients 12 years of age and older with pNET and epNET

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinal

FDA approves selpercatinib for medullary thyroid cancer with a RET mutation

Trial: LIBRETTO-531
Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Endocrine

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 approves selpercatinib for RET fusion-positive thyroid cancer

Trials: LIBRETTO-001, LIBRETTO-121
Drug: Retevmo (selpercatinib) · RET inhibitor
Condition: Endocrine

FDA grants accelerated approval to selpercatinib for pediatric patients two years and older with RET-altered metastatic thyroid cancer or solid tumors

Drug: Retevmo (selpercatinib) · RET inhibitor
Conditions: EndocrineOther solid neoplasm

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS

Trials: NETTER-P, NETTER-1
Drug: Lutathera (lutetium Lu 177 dotatate) · Radioactive agent
Condition: Endocrine

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 expands pediatric indication for entrectinib and approves new pellet formulation

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

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 approves cabozantinib for differentiated thyroid cancer

Drug: Cabometyx (cabozantinib) · VEGFR inhibitor
Condition: Endocrine

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 approves belzutifan for cancers associated with von Hippel-Lindau disease

Trial: MK-6482-004
Drug: Welireg (belzutifan) · HIF-2a inhibitor
Conditions: EndocrineGastrointestinalGenitourinaryNET

FDA approves pralsetinib for RET-altered thyroid cancers

Drug: GAVRETO (pralsetinib) · RET inhibitor
Condition: Endocrine

FDA approves pralsetinib for RET-altered thyroid cancers

Trial: ARROW
Drug: GAVRETO (pralsetinib) · RET inhibitor
Condition: Endocrine

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

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
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 selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

Drug: RETEVMO (selpercatinib) · RET inhibitor
Condition: Endocrine

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

Drug: RETEVMO (selpercatinib) · RET inhibitor
Condition: Endocrine

FDA approves larotrectinib for solid tumors with NTRK gene fusions

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

FDA approves iobenguane I 131 for rare adrenal gland tumors

Drug: AZEDRA (iobenguane I 131) · Radioactive agent
Condition: Endocrine

FDA approves dabrafenib plus trametinib for anaplastic thyroid cancer with BRAF V600E mutation

Drugs: TAFINLAR (dabrafenib) · BRAF inhibitor, MEKINIST (trametinib) · MEK inhibitor
Condition: Endocrine

FDA approves lutetium Lu 177 dotatate for treatment of GEP-NETS

Trial: NETTER-1
Drug: LUTATHERA (lutetium Lu 177 dotatate) · Radioactive agent
Condition: Endocrine

Lenvatinib in combination with Everolimus

Drugs: Lenvima (lenvatinib) · Multikinase inhibitor, everolimus · MTOR inhibitor
Conditions: EndocrineGenitourinary

Lenvatinib (Lenvima)

Drug: Lenvima (lenvatinib) · Multikinase inhibitor
Condition: Endocrine

Lanreotide

Drug: Somatuline Depot (lanreotide) · Somatostatin analog
Conditions: EndocrineNET

Sorafenib (NEXAVAR)

Drug: NEXAVAR tablets (sorafenib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinalGenitourinary

Cabozantinib

Drug: COMETRIQ capsules (cabozantinib) · VEGFR inhibitor
Condition: Endocrine

Sunitinib

Drug: Sutent Capsules (sunitinib) · VEGFR inhibitor
Conditions: EndocrineGastrointestinalNET

Everolimus 2011

Drug: Afinitor Tablets (everolimus) · MTOR inhibitor
Conditions: EndocrineGastrointestinalNET

Vandetanib

Drug: Vandetanib Tablets (vandetanib) · Multikinase inhibitor
Condition: Endocrine

Iobenguane I 123

Drug: AdreView (iobenguane I 123)
Conditions: CNSEndocrine