EMA

  • April 1. Abemaciclib – BC HR+/HER2-. EMA has approved the dual inhibitor of (CDK) 4/6 cyclin-dependent kinases, in combination with standard endocrine therapy for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence
  • April 5. Nivolumab + ipilimumab – ESCC PD-L1. The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumour cells.
  • April 5. Nivolumab – MIUC/OSCC PD-L1. The European Commission has approved nivolumab for use in the adjuvant treatment of adult patients with muscle-invasive urothelial carcinoma and a PD-L1 expression of 1% or higher on tumour cells, who are at a high risk of recurrence and, in combination with fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma whit a PD-L1 expression of 1% or higher on tumour cells.
  • April 29. Pembrolizumab – CRC/EC/BTC/SBA/GC MSI. The European Commission has granted an approval to pembrolizumab for the treatment of patients with the following microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) solid tumors:
  • unresectable or metastatic colorectal cancer after prior fluoropyrimidine-based combination therapy;
  • advanced or recurrent endometrial carcinoma who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation;
  • unresectable or metastatic gastric, small intestine or biliary cancer who have disease progression on or following at least 1 prior therapy.
  • April Pembrolizumab – CC PD-L1. The European Commission has granted an approval to the combination of pembrolizumab and chemotherapy, with or without bevacizumab, for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer whose tumors have a PD-L1 combined positive score (CPS) of 1 or higher.

CHMP

  • April 22. Capmatinib – NSCLC MET. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for capmatinib, intended for treatment of patients with advanced non-small cell lung cancer harbouring alterations leading to MET gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
  • April 22. Pembrolizumab – TNBC. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for the drug. Pembrolizumab, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple negative breast cancer at high risk of recurrence.
  • April 22. Selpercatinib – NSCLC RET. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted an extension to an existing indication as follows: selpercatinib as monotherapy is indicated for the treatment of adults with advanced RET fusion positive non-small cell lung cancer not previously treated with a RET inhibitor.
  • April 22. Atezolizumab – NSCLC EGFR/ALK. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a new indication for the drug. Atezolizumab as monotherapy is indicated as adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ? 50% of tumour cells and who do not have EGFR mutant or ALK-positive NSCLC.

FDA

  • April 6. Alpelisib – PROS PIK3CA. The FDA granted accelerated approval to alpelisib for adult and pediatric patients with severe manifestations of PIK3CA-related overgrowth spectrum who require systemic therapy.
  • April 19. Trastuzumab deruxtecan – NSCLC HER2. The FDA granted Priority Review to a supplemental biologics license application for trastuzumab deruxtecan as treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have a HER2 mutation and who have received a prior systemic therapy
  • April 27. Trastuzumab deruxtecan – BC HER2. The FDA granted Breakthrough Therapy Designation to trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy in the metastatic setting or who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
  • April 27. SQZ-PBMC-HPV – solid tumours HPV. The FDA granted Fast Track Designation to the vaccin for the treatment of patients with HPV16-positive advanced or metastatic solid tumours.