FDA Oncology Announcements

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38 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 vimseltinib for symptomatic tenosynovial giant cell tumor

Trial: MOTION
Drug: Romvimza (vimseltinib) · CSF1R inhibitor
Condition: Sarcoma

FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection

Drug: Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) · Anti-PD-L1 antibody
Conditions: DermatologicGastrointestinalSarcomaThoracic

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

Drug: TECELRA (afamitresgene autoleucel) · Anti-MAGE-A4 SPEAR T-cell
Condition: Sarcoma

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 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 nirogacestat for desmoid tumors

Trial: DeFi
Drug: OGSIVEO (nirogacestat) · Gamma secretase inhibitor
Condition: Sarcoma

FDA expands pediatric indication for entrectinib and approves new pellet formulation

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

FDA grants approval to atezolizumab for alveolar soft part sarcoma

Drug: Tecentriq (atezolizumab) · Anti-PD-L1 antibody
Condition: Sarcoma

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 approves crizotinib for ALK-positive inflammatory myofibroblastic tumor

Drug: Xalkori (crizotinib) · ALK inhibitor
Condition: Sarcoma

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 sirolimus protein-bound particles for malignant perivascular epithelioid cell tumor

Trial: AMPECT
Drug: sirolimus protein-bound particles · MTOR inhibitor
Condition: Sarcoma

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 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 ripretinib for advanced gastrointestinal stromal tumor

Trial: INVICTUS
Drug: QINLOCK (ripretinib) · PDGFR inhibitor
Condition: Sarcoma

FDA approves ripretinib for advanced gastrointestinal stromal tumor

Trial: INVICTUS
Drug: QINLOCK (ripretinib) · PDGFR inhibitor
Condition: Sarcoma

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug: POMALYST (pomalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Sarcoma

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

Drug: POMALYST (pomalidomide) · Immunomodulatory drugs (IMiDs)
Condition: Sarcoma

FDA approves tazemetostat for advanced epithelioid sarcoma

Drug: TAZVERIK (tazemetostat) · EZH inhibitor
Condition: Sarcoma

FDA approves tazemetostat for advanced epithelioid sarcoma

Drug: TAZVERIK (tazemetostat) · EZH inhibitor
Condition: Sarcoma

FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation

Drug: AYVAKITTM (avapritinib) · PDGFR inhibitor
Condition: Sarcoma

FDA approves avapritinib for gastrointestinal stromal tumor with a rare mutation

Drug: AYVAKIT (avapritinib) · PDGFR inhibitor
Condition: Sarcoma

FDA approves pexidartinib for tenosynovial giant cell tumor

Trial: ENLIVEN
Drug: TURALIO (pexidartinib) · Multikinase inhibitor
Condition: Sarcoma

FDA approves larotrectinib for solid tumors with NTRK gene fusions

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

Olaratumab (LARTRUVO)

Drug: LARTRUVO (olaratumab) · Anti-PDGFR antibody
Condition: Sarcoma

Eribulin

Drug: HALAVEN (eribulin) · Non-taxane microtubule dynamics inhibitor
Condition: Sarcoma

Trabectedin

Drug: Yondelis (trabectedin) · Alkylating agent
Condition: Sarcoma

FDA Approves Denosumab

Drug: Xgeva (denosumab) · Anti-RANKL antibody
Condition: Sarcoma

Doxorubicin Hydrochloride Liposome (Injection)

Drug: doxorubicin hydrochloride liposome · Anthracycline
Conditions: GynecologicSarcoma

FDA approves Pazopanib for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy

Drug: VOTRIENT (pazopanib) · VEGFR inhibitor
Condition: Sarcoma

Imatinib Mesylate Tablets

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Condition: Sarcoma

Imatinib Mesylate

Drugs: Gleevec (imatinib mesylate tablets for oral use) · Bcr-Abl inhibitor, Gleevec (oral use)
Condition: Sarcoma

FDA approves imatinib mesylate (Gleevec) as a single agent for the treatment of multiple indications

Drug: Gleevec (imatinib mesylate) · Bcr-Abl inhibitor
Conditions: MyeloidSarcoma