EMA

  • November 15 – Dabrafenib – LGG/HGG BRAF. The BRAF inhibitor has been approved in the European Union for the following therapeutic indications:
  • treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy, in combination with trametinib;
  • 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, in combination with trametinib.
  • December 18 – Pembrolizumab – GC/GEJ HER2/PD-L1. The European Commission has approved pembrolizumab in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment for patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma and a PD-L1 combined positive score (CPS) of at least 1.
  • January 5 – Trametinib – LGG/HGG BRAF. The MEK inhibitor has been approved by the European Commission for the following therapeutic indications:
  • treatment of paediatric patients aged 1 year and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy, in combination with dabrafenib;
  • 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, in combination with dabrafenib.
  • January 10 – Adagrasib – NSCLC KRAS. The European Commission has granted conditional marketing authorization to the KRAS inhibitor for use in adult patients with advanced non–small cell lung cancer harbouring a KRAS G12C mutation whose disease progressed following at least 1 prior systemic treatment.
  • January 12 –Dostarlimab – EC MSI. The European Commission (EC) has extended the therapeutic indication of the anti-PD-1 antibody to include, in combination with platinum-containing chemotherapy, the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.

 

CHMP

  • January 25 – Selpercatinib – TC RET. The Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for the RET receptor tyrosine kinase inhibitor to include treatment of adults and adolescents with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory.
  • February 22 – Tislelizumab – NSCLC EGFR/ALK. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the anti-PD-1 monoclonal antibody, intended for the treatment of locally advanced or metastatic non-small cell lung cancer either in monotherapy or in combination with chemotherapy. In particular, Tislelizumab in combination with pemetrexed and platinum?containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on >50% of tumour cells with no EGFR or ALK positive mutations. Moreover, Tislelizumab as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic EGFR mutant or ALK positive NSCLC after prior platinum-based therapy.

 

FDA

  • January 19 – Erdafitinib – UC FGFR3. The Food and Drug Administration approved the FGFR tyrosine kinase inhibitor for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.
  • February 15 – Tepotinib – NSCLC MET. The Food and Drug Administration granted traditional approval to the MET tyrosine kinase inhibitor for adult patients with metastatic non-small cell lung cancer harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
  • February 16 – Osimertinib – NSCLC EGFR. The Food and Drug Administration (FDA) approved the 3rd generation EGFR tyrosine kinase inhibitor in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer (la/mNSCLC) whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
  • December 13 – Naporafenib – CM NRAS. The Food and Drug Administration (FDA) has granted fast track designation to naporafenib plus trametinib for use as a potential therapeutic option in adult patients with unresectable or metastatic melanoma with an NRAS mutation who progressed on or are intolerant to a PD-1/PD-L1–based regimen.
  • January 18 – Avutometinib + sotorasib – NSCLC KRAS. The Food and Drug Administration (FDA) has granted a fast track designation to avutometinib, in combination with sotorasib, for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer who have received at least 1 prior systemic therapy and have not been previously treated with a KRAS G12C inhibitor.
  • January 29 – T-Dxd – solid tumours HER2. Trastuzumab deruxtecan (T-Dxd) has been granted priority review by the Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic HER2+ tumours who have received prior treatment or who have no suitable treatment options available.
  • January 31 – Alectinib – NSCLC ALK. The Food and Drug Administration (FDA) has granted priority review to a supplemental New Drug Application seeking the approval of alectinib for use as adjuvant treatment after surgery in patients with early-stage ALK-positive non–small cell lung cancer.
  • February 6 – Vepdegestrant – BC ER/HER2. The Food and Drug Administration (FDA) has granted a fast track designation to vepdegestrant as a monotherapy for the treatment of adult patients with ER+/HER2- locally advanced or metastatic breast cancer that received prior treatment with endocrine-based therapy.
  • February 14 – Repotrectinib – solid tumours NTRK. The Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental New Drug Application for the next-generation TKI repotrectinib in the treatment of adult and paediatric patients 12 years of age and older with NTRK-positive, locally advanced or metastatic solid tumours for whom surgical resection is likely to result in severe morbidity.
  • February 20 – Vorasidenib – Glioma IDH. The Food and Drug Administration (FDA) has filed an acceptance and priority review for a new drug application (NDA) for vorasidenib for the treatment of patients with IDH-mutant diffuse glioma.
  • February 20 – Adagrasib + cetuximab – CRC KRAS. The Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for adagrasib in combination with cetuximab for the treatment of patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer.
  • February 26 – BAY 2927088 – NSCLC HER2. The Food and Drug Administration (FDA) has granted a breakthrough therapy designation to BAY 2927088 (a small molecule tyrosine kinase inhibitor) for patients with non-small cell lung cancer harbouring HER2-activating mutations.
  • February 27 –NVL-520 – NSCLC ROS1. The Food and Drug Administration (FDA) has granted a breakthrough therapy designation to NVL-520 for the treatment of patients with metastatic ROS1-positive non–small cell lung cancer who previously received at least 2 ROS1 TKIs.