EMA

  • August 4 –  Olaparib – BC BRCA1/2. The European Commission has approved the PARP inhibitor as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
  • August 29 –  Asciminib – Ph+ CML-CP. The European Commission has approved the BCR-ABL tyrosine kinase inhibitor for the treatment of patients with Philadelphia chromosome (Ph)–positive chronic myeloid leukemia in chronic phase who received prior treatment with at least two tyrosine kinase inhibitors (TKIs). Asciminib has also been shown to be effective in patients with the T315L mutation, which confers resistance to most TKIs.

FDA

  • August 5 – Fam-trastuzumab deruxtecan-nxki – BC HER2. The FDA approved the HER2-directed antibody-drug conjugate for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
  • August 10 – Capmatinib – NSCLC MET. The FDA converted from accelerated to regular the approval to the MET tyrosine kinase inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping (METex14).
  • August 11 – Fam-trastuzumab deruxtecan-nxki – NSCLC HER2. The FDA granted accelerated approval to the HER2-directed antibody-drug conjugate for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, and who have received a prior systemic therapy.
  • August 26 – Pemigatinib – MLNs FGFR1. The FDA approved the FGFR tyrosine kinase inhibitor for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement.
  • August 3 – Taletrectinib – NSCLC ROS1. The FDA has granted a breakthrough therapy designation to this ROS1 inhibitor for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who were ROS1 inhibitor naïve or who previously received crizotinib.
  • August 11 – Elacestrant – BC ER/HER2. The FDA has granted the Priority Review to the investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. Elacestrant has also been shown to be effective in patients whose tumours harbour an ESR1