EMA

  • October 3 –  Olaparib – BC BRCA1/2. The European Commission has extended the indication of the drug to include the use of the PARP inhibitor as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

FDA

  • October 11 – Sacituzumab govitecan – BC HR/HER2. The FDA has granted priority review to the Trop-2 directed antibody-drug conjugate for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
  • October 24 – Quizartinib – AML FLT3. The FDA has granted priority review to the FLT3 inhibitor in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for adult patients with newly diagnosed, FLT3-ITD-positive acute myeloid leukemia (AML)
  • October 3 – Sapanisertib – NSCLC NRF2. The FDA has granted a fast track designation to the mTORC 1/2 inhibitor for adult patients with unresectable or metastatic squamous non–small cell lung cancer (NSCLC) who harbor a mutation in nuclear factor erythroid 2-related factor (NRF2) and have received prior platinum-based chemotherapy and immune checkpoint inhibitor therapy.
  • October 4 – CUE-101 – HNSCC HPV. The FDA has granted fast track designation to the interleukin 2 (IL-2)-based biologic for the treatment of patients with human papillomavirus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab.
  • October 4 – Eftilagimod alpha – NSCLC PD-L1. The FDA has granted a fast track designation to the antigen presenting cell (APC) activator for use in combination with pembrolizumab as a frontline treatment for patients with stage IIIB/IV non–small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score (TPS) of at least 1%.
  • October 11 – BBP-398 – NSCLC KRAS. The FDA has granted fast track designation (FTD) to the SHP2 inhibitor in combination with sotorasib for the treatment of adult patients with previously-treated, KRAS G12C-mutated, metastatic non–small cell lung cancer (NSCLC).