FDA Oncology Announcements

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13 Announcements

FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Trial: KOMET
Drug: KOSELUGO (selumetinib) · MEK inhibitor

FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug: KOSELUGO (selumetinib) · MEK inhibitor

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 selumetinib for neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas

Drug: KOSELUGO (selumetinib) · MEK inhibitor

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 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

Cobimetinib

Drug: COTELLIC Tablets (cobimetinib) · MEK inhibitor

FDA Approves Trametinib

Drug: MEKINIST tablet (trametinib) · MEK inhibitor