EMA

  • October 18 – Trastuzumab deruxtecan – NSCLC HER2. The European Commission (EC) has approved the HER2-specific antibody-drug conjugate (ADC) to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
  • November 6 – Quizartinib – AML FLT3. The FLT3 inhibitor has been approved in the European Union (EU) for use in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD

CHMP

  • November 9 – Trametinib – LGG/HGG BRAF. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the MEK1/MEK2 inhibitor, intended for the treatment of low- and high-grade glioma. Trametinib in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. Trametinib in combination with dabrafenib is indicated for the treatment of paediatric patients aged 1 year and older with high-grade glioma (HGG) with a BRAF V600E mutation who have received at least one prior radiation and/or chemotherapy treatment.
  • November 9 – Adagrasib – NSCLC KRAS. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a conditional marketing authorisation for the KRAS inhibitor, intended for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and disease progression after at least one prior systemic therapy. 

FDA

  • November 16 – Capivasertib – BC HR/HER2/ PIK3CA/AKT1/PTEN. The Food and Drug Administration (FDA) approved the inhibitor of all 3 isoforms of serine/threonine kinase AKT (AKT1, AKT2, and AKT3) with fulvestrant for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as detected by an FDA-approved test, following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
  • November 16 – Pembrolizumab – GC/GEJ HER2. The Food and Drug Administration (FDA) approved the anti-PD-1 antibody with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
  • November 15 – Repotrectinib – NSCLC ROS1. The Food and Drug Administration (FDA) approved the tyrosine kinase inhibitor of ROS1 and TRKA/B/C for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
  • November 28 – Zotatifin+fulvestrant+abemaciclib – BC HR/HER2. The Food and Drug Administration (FDA) has granted a fast track designation to the inhibitor of the RNA helicase eIF4A in combination with fulvestrant and abemaciclib as a second- or third-line treatment for adult patients with estrogen receptor (ER)-positive (HR+)/HER2-negative (HER2–) advanced or metastatic breast cancer with disease progression following treatment with endocrine therapy and a CDK 4/6 inhibitor.