EMA

  • September 16 – Nivolumab + relatlimab – melanoma PD-L1. The European Commission (EC) has approved the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression <1%.

CHMP.

  • September 15 – Crizotinib – ALCL/IMT ALK. The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of indications for the ALK and ROS1 inhibitor. The new indications concern the treatment of paediatric patients with relapsed or refractory systemic ALK-positive anaplastic large cell lymphoma (ALCL) and the treatment of paediatric patients with recurrent or refractory ALK positive unresectable inflammatory myofibroblastic tumour (IMT).

FDA

  • September 21 – Selpercatinib – solid tumours RET. The FDA granted accelerated approval to the RET inhibitor for adult patients with locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
  • September 21 – Selpercatinib – NSCLC RET. The FDA has converted from accelerated to regular the approval of selpercatinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test.
  • September 30 – Futibatinib – iCCA FGFR2. The FDA granted accelerated approval to the selective tyrosine kinase inhibitor of FGFR1-4 for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harbouring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
  • September 21 – KIN-2787 – melanoma BRAF/NRAS. has granted Fast Track designation for the investigational pan-RAF inhibitor for treatment of patients with BRAF Class II or III alteration-positive and/or NRAS mutation-positive stage IIb to IV malignant melanoma that is metastatic or unresectable.
  • September 19 – Tucatinib – CRC HER2. The tyrosine kinase inhibitor of HER2, in combination with trastuzumab, granted Priority Review by FDA for adult patients with HER2-positive colorectal cancer who have received at least one prior treatment regimen for unresectable or metastatic disease.