EMA

  • May 23. Pembrolizumab – TNBC. The European Commission approved the anti-PD-1 antobody for use in combination with chemotherapy as neoadjuvant therapy, and then continued as monotherapy as adjuvant treatment after surgery for adults with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.

FDA

  • May 4. Trastuzumab deruxtecan – BC HER2. The FDA approved the HER2-directed antibody and topoisomerase inhibitor conjugate for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.
  • May 25. Ivosidenib – AML IDH1. The FDA approved the IDH1 inhibitor in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
  • May 23. Farletuzumab ecteribulin – OC FR?. The FDA granted Priority Review to the anti-FR? antibody linked to the cytotoxic microtubule inhibitor for the treatment of patients with platinum-resistant ovarian cancer whose tumour cells express high levels of folate receptor-alpha [FR?].
  • May 10. Repotrectinib – NSCLC ROS1. The FDA has granted a Breakthrough Therapy Designation to the ROS1 and TRK tyrosine kinase inhibitor for the treatment of patients with ROS1-positive metastatic non-small cell lung cancer who have previously treated with one ROS1 TKI and have not received prior platinum-based chemotherapy.
  • May 4. HM43239 – AML FLT3. The FDA has granted a Fast Track Designation to the myeloid kinome inhibitor for use as a potential therapeutic option in patients with relapsed or refractory acute myeloid leukemia whose tumours harbour a FLT3 mutation.
  • May 25. Seribantumab – Solid tumours NRG1. The FDA has granted a Fast Track Designation to the HER3-targeted monoclonal antibody for the tumour-agnostic treatment of advanced solid tumours that harbour NRG1 gene fusions.