EMA

  • June 17 – Capivasertib – BC PIK3CA/AKT1/PTEN. The European Commission (EC) has authorised the marketing of the serine/threonine kinase inhibitor. Capivasertib is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.
  • July 3 – Entrectinib – Solid Tumours NTRK. The European Commission (EC) has approved the extension of the currently approved indication of the TRK, ROS1 and ALK tyrosine kinase inhibitor in solid tumours with NTRK gene fusion to patients from 1 month to 12 years of age.
  • July 5 – Osimertinib – NSCLC EGFR. The third-generation, irreversible EGFR-TKI with the addition of pemetrexed and platinum-based chemotherapy has been approved in the European Union for the 1st-line treatment of adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
  • July 26 – Sugemalimab – NSCLC EGFR/ALK/ROS1/RET. The European Commission (EC) has approved the anti-PD-L1 monoclonal antibody in combination with platinum-based chemotherapy for the first-line treatment of adults with metastatic non-small-cell lung cancer (NSCLC) with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
  • August 22 – Erdafitinib – UC FGFR3. The European Commission (EC) has approved the FGFR tyrosine kinase inhibitor for the treatment of patients with unresectable or metastatic urothelial carcinoma (UC) harbouring susceptible FGFR3 genetic alterations and who have worsened after immunotherapy.
  • August 27 – Amivantamab – NSCLC EGFR. The European Commission (EC) has approved an extension of indication for the anti-EGFR-MET bispecific antibody in combination with chemotherapy (carboplatin and pemetrexed), for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 19 deletions (ex19del) or Exon 21 L858R substitution (L858R) mutations, after failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI).
  • August 30 – Encorafenib + Binimetinib – NSCLC BRAF. The European Commission (EC) has approved encorafenib (BRAF inhibitor) in combination with binimetinib (MEK 1/2 inhibitor) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E

FDA

  • August 6 – Vorasidenib – A-II/ODG IDH1/2. The Food and Drug Administration (FDA) approved the isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with grade 2 astrocytoma (A-II) or oligodendroglioma (ODG) with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.
  • August 15 – Durvalumab – NSCLC EGFR/ALK. The Food and Drug Administration (FDA) approved the anti-PD-L1 monoclonal antibody with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
  • August 19- Lazertinib – NSCLC EGFR. The Food and Drug Administration (FDA) approved the 3rd generation EGFR-TKI in combination with amivantamab-vmjw for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
  • July 15 – DSP-5336 – AML KMT2A/NPM1. The Food and Drug Administration (FDA) granted fast track designation to the investigational inhibitor of the menin and mixed-lineage leukemia (MLL) protein interaction for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with a KMT2A rearrangement (or mixed lineage leukemia rearrangement, MLLr) or nucleophosmin mutation (NPM1m).
  • July 29 – Asciminib – CML BCR-ABL1. Asciminib has been granted priority review status by the US Food and Drug Administration (FDA) for treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
  • August 14- AC699 – BC ESR1. The US Food and Drug Administration (FDA) has granted the chimeric degrader of estrogen receptor (ER) ? a fast track designation for the treatment of patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression on or after at least 1 line of endocrine-based therapy.
  • August 27 – Zongertinib – NSCLC HER2. The U.S. Food and Drug Administration (FDA) granted the HER2-specific tyrosine kinase inhibitor breakthrough therapy designation for the treatment of adult patients with advanced, unresectable or metastatic non-small cell lung cancer harboring HER2 mutations who have received a prior systemic therapy.