FDA Oncology Announcements

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16 Announcements

FDA grants traditional approval to encorafenib for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

FDA grants accelerated approval to encorafenib with cetuximab and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

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 approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation

Drugs: Braftovi (encorafenib) · BRAF inhibitor, Mektovi (binimetinib) · MEK inhibitor
Condition: Thoracic

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 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 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 encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

Trial: BEACON CRC
Drugs: BRAFTOVI (encorafenib) · BRAF inhibitor, cetuximab · Anti-EGFR antibody
Condition: Gastrointestinal

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 anaplastic thyroid cancer with BRAF V600E mutation

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

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 granted approval to vemurafenib for Erdheim-Chester Disease

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

FDA grants regular approval to dabrafenib and trametinib combination for metastatic NSCLC with BRAF V600E mutation

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

Trametinib/Dabrafenib

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

Dabrafenib

Drug: TAFINLAR capsule (dabrafenib) · BRAF inhibitor

Vemurafenib

Drug: ZELBORAF (vemurafenib) · BRAF inhibitor