EMA

  • February 18 – tepotinib – NSCLC METex14: EMA has approved the MET inhibitor as monotherapy for the treatment of adult patients with advanced NSCLC harbouring alterations leading to MET gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

CHMP

  • February 24 – tebentafusp – UM HLA-A*02:01: the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for tebentafusp as monotherapy for the treatment of HLA-A*02:01 positive adult patients with unresectable or metastatic uveal melanoma.
  • February 24 – abemaciclib – BC HR+/HER2-: the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending an extension to the existing indication to include use in early HR+/HER2- node-positive breast cancer at high risk of recurrence.
  • February 24 – ipilimumab – OSCC PD-L1: the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for a new therapeutic indication: first-line treatment, in combination with nivolumab, of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1
    expression> 1%.
  • February 24 – nivolumab – OSCC and MIUC PD-L1: the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for three new therapeutic indications.

-Nivolumab in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression > 1%.
-Nivolumab in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression > 1%.
-Nivolumab as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma with tumour cell PD-L1 expression >1%, who are at high risk of recurrence after undergoing radical resection of tumour.

FDA

  • February 24 – THE-630 – GIST KIT: FDA granted Orphan Drug Designation (ODD) to the pan-variant KIT inhibitor for the treatment of patients with advanced gastrointestinal stromal tumours.