FDA Oncology Announcements

EGFR inhibitor × Thoracic × Clear all

10 Announcements

FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Drug: Zegfrovy (sunvozertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves osimertinib for locally advanced, unresectable (stage III) non-small cell lung cancer following chemoradiation therapy

Trial: LAURA
Drug: Tagrisso (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer

Trial: MARIPOSA
Drugs: Lazcluze (lazertinib) · EGFR inhibitor, Rybrevant (amivantamab-vmjw) · Anti-EGFR-HGFR bispecific antibody
Condition: Thoracic

FDA approves osimertinib with chemotherapy for EGFR-mutated non-small cell lung cancer

Trial: FLAURA2
Drug: Tagrisso (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA grants accelerated approval to mobocertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations

Drug: Exkivity (mobocertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves osimertinib as adjuvant therapy for non-small cell lung cancer with EGFR mutations

Trial: ADAURA
Drug: TAGRISSO (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

Trial: RELAY
Drugs: CYRAMZA (ramucirumab) · Anti-VEGFR antibody, erlotinib · EGFR inhibitor
Condition: Thoracic

FDA approves dacomitinib for metastatic non-small cell lung cancer

Drug: VIZIMPRO (dacomitinib) · EGFR inhibitor
Condition: Thoracic

FDA approves osimertinib for first-line treatment of metastatic NSCLC with most common EGFR mutations

Trial: FLAURA
Drug: Tagrisso (osimertinib) · EGFR inhibitor
Condition: Thoracic

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

Drug: Gilotrif (afatinib) · EGFR inhibitor
Condition: Thoracic