FDA Oncology Announcements

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54 Announcements

FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

Drug: Libtayo (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Dermatologic

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 nivolumab and hyaluronidase-nvhy for subcutaneous injection

Trial: CheckMate-67T
Drugs: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) · Anti-PD-1 antibody, Opdivo (nivolumab) · Anti-PD-1 antibody
Conditions: DermatologicGastrointestinalGenitourinaryHead & NeckThoracic

FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug: Unloxcyt (cosibelimab-ipdl) · Anti-PD-L1 antibody
Condition: Dermatologic

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 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 grants accelerated approval to lifileucel for unresectable or metastatic melanoma

Trial: LN-144
Drug: Amtagvi (lifileucel) · Mononuclear cell vaccine
Condition: Dermatologic

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 nivolumab for adjuvant treatment of Stage IIB/C melanoma

Trial: CheckMate76K
Drug: Opdivo (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves melphalan as a liver-directed treatment for uveal melanoma

Trial: FOCUS
Drug: HEPZATO KIT (melphalan) · Nitrogen mustard
Condition: Dermatologic

FDA grants accelerated approval to retifanlimab-dlwr for metastatic or recurrent locally advanced Merkel cell carcinoma

Drug: Zynyz (retifanlimab-dlwr) · Anti-PD-1 antibody
Condition: Dermatologic

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 Opdualag for unresectable or metastatic melanoma

Trial: RELATIVITY-047
Drug: Opdualag (nivolumab and relatlimab-rmbw) · Multi-ingredient
Condition: Dermatologic

FDA approves tebentafusp-tebn for unresectable or metastatic uveal melanoma

Drug: Kimmtrak (tebentafusp-tebn) · Bispecific gp100 peptide-HLA-directed CD3 T-cell engager
Condition: Dermatologic

FDA approves pembrolizumab for adjuvant treatment of Stage IIB or IIC melanoma

Trial: KEYNOTE-716
Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

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 cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma

Drug: cemiplimab-rwlc · Anti-PD-1 antibody
Condition: Dermatologic

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 atezolizumab for BRAF V600 unresectable or metastatic melanoma

Drugs: Tecentriq (atezolizumab) · Anti-PD-L1 antibody, cobimetinib · MEK inhibitor, vemurafenib · BRAF inhibitor
Condition: Dermatologic

FDA approves atezolizumab for BRAF V600 unresectable or metastatic melanoma

Drugs: Tecentriq (atezolizumab) · Anti-PD-L1 antibody, cobimetinib · MEK inhibitor, vemurafenib · BRAF inhibitor
Condition: Dermatologic

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial: MK-3475-629
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

Trial: MK-3475-629
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

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 new dosing regimen for pembrolizumab

Trial: KEYNOTE-555
Drugs: KEYTRUDA (400 mg every six weeks for pembrolizumab) , KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for adjuvant treatment of melanoma

Trial: MK-3475-054
Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves pembrolizumab for Merkel cell carcinoma

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves larotrectinib for solid tumors with NTRK gene fusions

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

FDA approves cemiplimab-rwlc for metastatic or locally advanced cutaneous squamous cell carcinoma

Drug: LIBTAYO (cemiplimab-rwlc) · Anti-PD-1 antibody
Condition: Dermatologic

FDA approves encorafenib and binimetinib in combination for unresectable or metastatic melanoma with BRAF mutations

Trial: COLUMBUS
Drug: BRAFTOVI and MEKTOVI (encorafenib and binimetinib) · BRAF inhibitor
Condition: Dermatologic

FDA approves dabrafenib plus trametinib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations

Trial: COMBI-AD
Drugs: TAFINLAR (dabrafenib) · BRAF inhibitor, MEKINIST (trametinib) · MEK inhibitor
Condition: Dermatologic

FDA grants regular approval to nivolumab for adjuvant treatment of melanoma

Trial: CheckMate 238
Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA grants marketing approval to FoundationOne CDx in vitro diagnostic

Conditions: BreastDermatologicGastrointestinalGynecologicThoracic

Modification of the Dosage Regimen for Nivolumab

Conditions: DermatologicGenitourinaryThoracic

Pembrolizumab label updated with new clinical trial information

Drug: Keytruda (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

Trametinib/Dabrafenib

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

Cobimetinib

Drug: COTELLIC Tablets (cobimetinib) · MEK inhibitor
Condition: Dermatologic

Ipilimumab (Yervoy)

Condition: Dermatologic

Talimogene Laherparepvec

Drug: IMLYGIC (talimogene laherparepvec) · Oncolytic viral therapy
Condition: Dermatologic

Nivolumab in combination with ipilimumab

Drugs: Opdivo (nivolumab) · Anti-PD-1 antibody, ipilimumab · Anti-CTLA-4 antibody
Condition: Dermatologic

Sonidegib

Drug: Odomzo Capsules (sonidegib) · SMO inhibitor
Condition: Dermatologic

Nivolumab (Opdivo)

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Conditions: DermatologicThoracic

Nivolumab

Drug: OPDIVO (nivolumab) · Anti-PD-1 antibody
Condition: Dermatologic

Pembrolizumab

Drug: KEYTRUDA (pembrolizumab) · Anti-PD-1 antibody
Condition: Dermatologic

FDA Approves Trametinib

Drug: MEKINIST tablet (trametinib) · MEK inhibitor
Condition: Dermatologic

Dabrafenib

Drug: TAFINLAR capsule (dabrafenib) · BRAF inhibitor
Condition: Dermatologic

Vismodegib

Drug: ERIVEDGE Capsule (vismodegib) · SMO inhibitor
Condition: Dermatologic

Vemurafenib

Drug: ZELBORAF (vemurafenib) · BRAF inhibitor
Condition: Dermatologic

Peginterferon alfa-2b

Drug: Sylatron (peginterferon alfa-2b) · Interferon
Condition: Dermatologic

Ipilimumab

Drug: YERVOY (ipilimumab) · Anti-CTLA-4 antibody
Condition: Dermatologic