FDA Oncology Announcements

18 Announcements

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

FDA approves new interchangeable biosimilar to Perjeta

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA amends pembrolizumab’s gastric cancer indication

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

FDA approves margetuximab for metastatic HER2-positive breast cancer

FDA approves margetuximab for metastatic HER2-positive breast cancer

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

FDA approves new formulation of Herceptin for subcutaneous use

FDA approves Herzuma as a biosimilar to Herceptin

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

FDA approves Ogivri as a biosimilar to Herceptin

Pertuzumab Injection

FDA Approves Pertuzumab

FDA Appoves Trastuzumab (Herceptin)

FDA Expands the Use of Trastuzumab (Herceptin) for Early Stage Breast Cancer After Primary Therapy

FDA approves fam-trastuzumab deruxtecan-nxki with pertuzumab for unresectable or metastatic HER2-positive breast cancer

FDA approves new interchangeable biosimilar to Perjeta

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

FDA amends pembrolizumab’s gastric cancer indication

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

FDA approves margetuximab for metastatic HER2-positive breast cancer

FDA approves margetuximab for metastatic HER2-positive breast cancer

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

FDA approves combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf for HER2-positive breast cancer

FDA approves new formulation of Herceptin for subcutaneous use

FDA approves Herzuma as a biosimilar to Herceptin

FDA grants regular approval to pertuzumab for adjuvant treatment of HER2-positive breast cancer

FDA approves Ogivri as a biosimilar to Herceptin

Pertuzumab Injection

FDA Approves Pertuzumab

FDA Appoves Trastuzumab (Herceptin)

FDA Expands the Use of Trastuzumab (Herceptin) for Early Stage Breast Cancer After Primary Therapy

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)