CHMP (Committee for Medicinal Products for Human Use- EMA)
March 26. Serplulimab – NSCLC EGFR/ALK/ROS1. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a new indication for the Anti-PD-1 monoclonal antibody: serplulimab in combination with carboplatin and pemetrexed is indicated for the first-line treatment of adult non-squamous non-small cell lung cancer (NSCLC) patients with no EGFR, ALK or ROS1 positive mutations and who have locally advanced NSCLC who are not candidates for surgery or radiotherapy, or metastatic NSCLC.
March 26. Trametinib – CM/DTC BRAF. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the MEK1/MEK2 inhibitor.
- Trametinib, as monotherapy or in combination with dabrafenib, is now indicated also for the treatment adolescents aged 12 years and older with unresectable or metastatic cutaneous melanoma with a BRAF V600 mutation.
- Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to or not eligible for radioactive iodine (RAI) who have progressed during or after prior systemic therapy
March 26. Selpercatinib – NSCLC/TC/Solid Tumours RET. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the RET receptor tyrosine kinase inhibitor.
- Selpercatinib as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.
- Selpercatinib as monotherapy is indicated for the treatment of adults and paediatric patients 12 years of age and older with:
– advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate);
– advanced RET-mutant medullary thyroid cancer (MTC);
– advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted.
March 26. Dabrafenib – CM BRAF. The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the BRAF inhibitor.
- Dabrafenib, as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with unresectable or metastatic cutaneous melanoma with a BRAF V600 mutation.
- Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.
EMA
March 17. Niraparib + Abiraterone acetate – mHSPC HRR. The European Commission (EC) has approved the extension of indication for the dual-action tablet to include niraparib/abiraterone acetate for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and HRR-mutations (germline and/or somatic), in combination with prednisone or prednisolone.
FDA
March 25. TRI-611– NSCLC ALK. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational molecular glue degrader (MGD) for the treatment of anaplastic lymphoma kinase–positive (ALK+) non-small cell lung cancer (NSCLC). The designation is specifically directed toward patients whose disease has progressed following treatment with 2 or more ALK tyrosine kinase inhibitors (TKIs).
March 30. Lirafugratinib – CCA FGFR2. The U.S. Food and Drug Administration (FDA) has granted a priority review to the highly selective oral FGFR2 inhibitor for the treatment of patients with cholangiocarcinoma (CCA) with FGFR2 fusions or rearrangements who have received prior therapy.
AIFA
March 13. Crizotinib – ALCL/IMT ALK. The Italian Medicines Agency (AIFA) has included the ALK/ROS1 tyrosine kinase receptor inhibitor on the list of medicines fully reimbursed by the National Health Service, restricted to adults only, for the treatment of ALK-positive anaplastic lymphoma and ALK-positive inflammatory myofibroblastic tumours that are unresectable, recurrent or refractory, from the first line of treatment.
March 26. Amivantamab – NSCLC EGFR. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new therapeutic indications of the EGF and MET receptor targeted antibody:
- amivantamab is indicated in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring activating EGFR exon 20 insertion mutations;
- amivantamab is indicated in combination with carboplatin and pemetrexed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or L858R substitution mutations in exon 21 following failure of prior therapy including an EGFR tyrosine kinase inhibitor (TKI);
- amivantamab is indicated in combination with lazertinib for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with exon 19 deletions or L858R substitution mutations in exon 21 of EGFR.
March 26. Lazertinib – NSCLC EGFR. The Italian Medicines Agency (AIFA) has approved the reimbursement of the third-generation, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) in combination with amivantamab for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with exon 19 deletions or L858R substitution mutations in exon 21 of EGFR.