FDA Oncology Announcements

ERBB2 inhibitor × Clear all

8 Announcements

FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer

Drug: Hernexeos (zongertinib) · ERBB2 inhibitor
Condition: Thoracic

FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer

Drug: Hyrnuo (sevabertinib) · ERBB2 inhibitor
Condition: Thoracic

FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations

Drug: Hernexeos (zongertinib) · ERBB2 inhibitor
Condition: Thoracic

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

Drugs: Tukysa (tucatinib) · ERBB2 inhibitor, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA approves tucatinib for patients with HER2-positive metastatic breast cancer

Trial: HER2CLIMB
Drug: TUKYSA (tucatinib) · ERBB2 inhibitor
Condition: Breast

FDA approves neratinib for metastatic HER2-positive breast cancer

Trial: NALA
Drugs: NERLYNX (neratinib) · ERBB2 inhibitor, capecitabine · Fluoropyrimidine
Condition: Breast

FDA approves neratinib for extended adjuvant treatment of early stage HER2-positive breast cancer

Trial: ExteNET
Drug: NERLYNX (neratinib) · ERBB2 inhibitor
Condition: Breast

Tykerb

Drug: Tykerb (lapatinib) · ERBB2 inhibitor