EMA

  • June 9 –  Atezolizumab – NSCLC PD-L1/EGFR/ALK. The European Commission has approved the anti-PD-L1 antibody as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer with a high risk of recurrence whose tumours express PD-L1 > 50% and who do not have EGFR mutant or ALK-positive NSCLC.
  •  June 22 – Capmatinib – NSCLC MET. The European Commission approved the MET inhibitor as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harbouring alterations leading to MET exon 14 (METex14) skipping.

CHMP

  • June 23 – trastuzumab deruxtecan – BC HER2. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the HER-2 directed antibody attached to a topoisomerase inhibitor. Trastuzumab deruxtecan as monotherapy now is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens.
  • June 23 – olaparib – BC BRCA. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for olaparib. The PARP inhibitor is indicated as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations (gBRCAm) who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy

FDA

  • June 22 – Dabrafenib + trametinib – solid tumours BRAF. The FDA granted accelerated approval to the combination of the two kinase inhibitors for the treatment of adult and paediatric patients > 6 years of age with unresectable or metastatic solid tumours with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options.
  • June 2 – PDS0101 + pembrolizumab – HNC HPV. The FDA has granted a Fast Track Designation to the PDS0101 vaccine for use in combination with the anti-PD1 antibody in patients with recurrent or metastatic HPV16-positive head and neck cancer.
  • June 15 – Dianhydrogalactitol – GBM methylation. The FDA has granted a Fast Track Designation to dianhydrogalactitol, a first-in-class small molecule therapeutic, for the treatment of patients with newly-diagnosed unmethylated glioblastoma. The fast track status comes from data of a phase 2 trial evaluating dianhydrogalactitol in patients with GBM who had an unmethylated promoter of the MGMT