CHMP

  • 11 November- Sotorasib-NSCLC KRAS G12C: The EMA’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for the conditional marketing authorisation of the drug for the treatment of adult patients with advanced NSCLC, positive for the KRAS G12C mutation, who have progressed after at least one previous line of systemic therapy.

EMA

  • 19 November- Pralsetinib-NSCLC-RET fusions: conditional marketing approval granted as monotherapy for first-line treatment of adult patients with advanced NSCLC with RET gene fusions
  • 22 November- Sacituzumab Govitecan-TNBC: marketing approval as monotherapy for use as second-line treatment of adult patients with non-operable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies with at least one of these in advanced stage.

FDA

  • 3 November- TT-00420 -CCA-FGFR2 variants: Fast Track designation for the treatment of patients with cholangiocarcinoma (CCA) without standard treatment options. TT-00420 is a multi-kinase inhibitor that has been shown to be highly effective against cancer cells with altered FGFR2.
  • 9 November- Bemcentinib-NSCLC-STK11: Fast Track designation for the treatment, in combination with an anti-PD-L1 agent, of patients with advanced or metastatic NSCLC with STK11 genetic variants and without others actionable mutations.
  • 13 November- MT-6402 -NSCLC- PDL1: Fast Track designation for treatment of patients with advanced NSCLC PD-L1+.
  • 30 November- Olaparib-BC-BRCA: granted ” Priority Review ” status as adjuvant therapy in patients with early-stage, high-risk, HER-2 negative breast cancer with BRCA genes mutations, previously treated with neoadjuvant or adjuvant chemotherapy.