EMA

March 11 – Amivantamab – NSCLC EGFR. The European Commission (EC) has approved a Type II variation extension of indication for the anti-EGFR-MET bispecific antibody to include the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions (ex19del) or exon 21 L858R substitution mutations, in combination with lazertinib.

March 14 – Entrectinib – Solid tumours NTRK. The European Commission (EC) has approved then extension of the currently approved indication of the tyrosine kinase inhibitor of TRKA/B/C, ROS1 and ALK to paediatric patients. Entrectinib, now, as monotherapy, is indicated for the treatment of adult and paediatric patients older than 1 month with solid tumours that have a NTRK gene fusion,

  • who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and
  • who have not received a prior NTRK inhibitor
  • who have no satisfactory treatment options.

CHMP

March 27 – Bosutinib – CML BCR-ABL. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the existing indications to extend the use of bosutinib to children aged 6 years and older with certain types of chronic myelogenous leukaemia.

The dual SRC and ABL tyrosine kinase inhibitor will be therefore indicated for the treatment of:

  • Adult and paediatric patients aged 6 years and older with newly-diagnosed (ND) chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).
  • Adult and paediatric patients aged 6 years and older with CP Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
  • Adult patients with CP, accelerated phase (AP), and blast phase (BP) Ph+ CML previously treated with one or more tyrosine kinase inhibitor(s) [TKI(s)] and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.

FDA

April 8 – Nivolumab + Ipilimumab – CRC MSI. The Food and Drug Administration (FDA) approved nivolumab (anti-PD-1 antibody) with ipilimumab (CTLA-4 blocking antibody) for adult and pediatric patients 12 years of age and older with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC). The FDA also converted the accelerated approval to regular approval for single agent nivolumab for adult and paediatric patients 12 years of age and older with MSI-H or dMMR metastatic CRC, that has progressed following fluoropyrimidine, oxaliplatin, and irinotecan.

April 10 – Larotrectinib – Solid tumours NTRK. The Food and Drug Administration (FDA) changed from accelerated to traditional the approval of the first-in-class TRK inhibitor for the treatment of adult and paediatric patients with solid tumours that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

April 29 – INX-315 – OC CCNE. The Food and Drug Administration (FDA) has granted Fast Track Designation to the selective CDK2 inhibitor for the treatment of CCNE1-amplified platinum-resistant/refractory ovarian cancer (OC).