CHMP

  • March 24 – pembrolizumab – CRC/EC/BTC/SBA/GC MSI-H and CC PD-L1+. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the following new indications for the anti-PD-1 antibody:
  • as monotherapy for the treatment of the following MSI-H or dMMR tumours in adults with:
  • unresectable or metastatic colorectal cancer after previous 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 one prior therapy;
  • in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS > 1.

FDA

  • March 11 – olaparib – BC mBRCA. The PARP inhibitorhas been approved by the FDA for the adjuvant treatment of patients with germline BRCA-mutated HER2-negative high-risk early breast cancer who have already been treated with chemotherapy.
  • March 21 – pembrolizumab – EC MSI-H. FDA approved the anti-PD-1 antibody as single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.
  • March 7 – ivosidenib – AML mIDH1. FDA granted Priority Review to the IDH1 inhibitor as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukaemia.
  • March 30 – futibatinib – CCA FGFR2. FDA granted Priority Review to the FGFR1-4 inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma who harbour FGFR2 gene rearrangement, including gene fusions.