FDA

  • January 19. Tucatinib + trastuzumab – CRC RAS/HER2. The FDA granted accelerated approval to the HER2 tyrosine kinase inhibitor in combination with trastuzumab for RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
  • January 27. Elacestrant – BC ER/HER2/ESR1. The FDA approved the estrogen receptor antagonist for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
  • January 20. DB-1303 – EC/HER2. The FDA has granted Fast Track Designation (FTD) to the antibody-drug conjugate, comprised of anti-HER2 monoclonal antibody, enzymatically cleavable peptide-linker, and a proprietary topoisomerase I inhibitor P1003, for the treatment of patients with advanced, recurrent or metastatic endometrial carcinoma with HER2 overexpression who have progressed on or after standard systemic treatment.