EMA
November 27. Sugemalimab – NSCLC EGFR/ALK/ROS1. The European Commission (EC) has approved the extension of indication for the anti-PD-L1 monoclonal antibody to include the treatment of unresectable stage III non‑small‑cell lung cancer (NSCLC) with no sensitising EGFR mutations, or ALK, ROS1 genomic tumour aberrations in adults whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy.
November 25. Asciminib – CML BCR/ABL. The European Commission has approved asciminib for the treatment of adult patients with chronic phase Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML). With this decision, the first STAMP inhibitor is now approved for use in all treatment lines, including both newly diagnosed and previously treated patients.
CHMP
November 13. Selumetinib – PN NF1. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the extension of the indication for the oral, selective MEK inhibitor to paediatric patients. Selumetinib as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties. NF1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene. Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves.
November 13. Imlunestrant– BC ESR1. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a marketing authorisation for the oral selective estrogen receptor degrader (SERD), intended for the treatment of adults with locally advanced or metastatic breast cancer with an activating ESR1-mutation.
FDA
November 13. Ziftomenib – AML NPM1. The U.S. Food and Drug Administration (FDA) has approved the menin inhibitor for adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible nucleophosmin 1 (NPM1) mutation who have no satisfactory alternative treatment options.
November 20. Sevabertinib- NSCLC HER2. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to the oral, reversible, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
November 10. AVZO-1418/DB-1418 – NSCLC EGFR. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the EGFR/HER3 bispecific antibody-drug conjugate (ADC) for the treatment of patients with unresectable, locally advanced or metastatic non–small cell lung cancer (NSCLC) harbouring an EGFR exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR TKI.
AIFA
October 28. Capivasertib – BC PIK3CA/AKT1/PTEN. The Italian Medicines Agency (AIFA) has approved the reimbursement of the selective AKT inhibitor, in combination with fulvestrant, for the treatment of adult patients with locally advanced or metastatic oestrogen receptor (ER)-positive, HER2-negative breast cancer, with one or more PIK3CA/AKT1/PTEN alterations following recurrence or progression during or after endocrine-based therapy.
November 11. Entrectinib – Solid Tumours NTRK. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new indication of the tyrosine kinase inhibitor of the neurotrophic receptor. Entrectinib monotherapy is indicated for the treatment of adult and paediatric patients over 1 month of age with solid tumours harbouring an NTRK gene fusion and
– which are affected by locally advanced or metastatic disease, or whose surgical resection could result in severe morbidity
– which have not been previously treated with a NTRK inhibitor
– which do not have satisfactory treatment options.