EMA

  • November 9 – Selpercatinib – NSCLC/MTC RET. The European Commission has extended the indication of the RET inhibitor to include first-line treatment both of RET fusion-positive non-small cell lung cancer (NSCLC) and advanced RET-mutant medullary thyroid cancer (MTC) in adults and adolescents 12 years and older.
  • December 2 – Crizotinib – ALCL/IMT ALK. The European Commission has extended the indication of the ALK and ROS1 inhibitor to include treatment of paediatric patients (age > 6 to < 18 years) with relapsed or refractory systemic anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and with unresectable, recurrent, or refractory ALK-positive inflammatory myofibroblastic tumour (IMT).
  • December 19 – Trastuzumab deruxtecan – GAC/GEJ HER2. The HER2-directed antibody-drug conjugate has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
    On November 10, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the same indication.

CHMP

  • December 15 – Trastuzumab deruxtecan – BC HER2. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for the HER2-directed antibody drug conjugate. Trastuzumab deruxtecan as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
  • December 15 – Tremelimumab – NSCLC EGFR/ALK. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for tremelimumab. The anti-CTLA-4 monoclonal antibody, in combination with durvalumab and platinum-based chemotherapy, is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
  • December 15 – Durvalumab – NSCLC EGFR/ALK. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a new indication for durvalumab. The anti-PD-L1 monoclonal antibody, in combination with tremelimumab and platinum-based chemotherapy, is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.

FDA

  • November 8 – Cemiplimab – NSCLC EGFR/ALK/ROS1. The FDA approved the anti-PD-1 antibody in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.
  • November 10 – Tremelimumab + durvalumab – NSCLC EGFR/ALK. The FDA approved tremelimumab (anti-CTLA-4 monoclonal antibody) in combination with durvalumab (anti-PD-L1 monoclonal antibody) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.
  • November 15 – Vebreltinib – NSCLC MET. The (FDA) has granted Orphan Drug Designation to vebreltinib (APL-101) for the treatment of non-small cell lung cancer (NSCLC) with MET genomic tumor aberrations.
  • December 1 – Olutasidenib – AML IDH1. The FDA approved the inhibitor of mutated IDH1 for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation.
  • December 12 – Adagrasib – NSCLC KRAS. The FDA granted accelerated approval to the RAS GTPase family inhibitor, for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.
  • December 5 – Revumenib – AML/ALL KMT2A. The FDA has granted a breakthrough therapy designation (BTD) to SNDX-5613 (revumenib) for the treatment of adult and pediatric patients with relapsed or refractory (R/R) acute leukemia (whether it presents clinically as acute myeloid leukemia or acute lymphocytic leukemia) harbouring a KMT2A rearrangement (KMT2Ar).
  • December 21 – Adagrasib – CRC KRAS. The FDA granted breakthrough therapy designation (BTD) to adagrasib in combination with cetuximab for the treatment of patients with KRAS G12C-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.