CHMP
December 11. Aumolertinib – NSCLC EGFR. 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 third-generation EGFR tyrosine kinase inhibitor for the treatment, as monotherapy, of:
- adult patients with advanced non small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (first line treatment);
- adult patients with advanced EGFR T790M mutation-positive NSCLC.
FDA
December 12. Niraparib + Abiraterone acetate – mCSPC BRCA2. The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for the dual-action tablet niraparib/abiraterone acetate plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). Patients with BRCA mutations often have more aggressive forms of prostate cancer leading to poor prognosis, representing a significant unmet need not addressed by 2 previously available therapies.
December 17. Rucaparib – mCRPC BRCA. The Food and Drug Administration (FDA) approved the poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of adults with a deleterious BRCA mutation (BRCAm) (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) previously treated with an androgen receptor-directed therapy. Patients should be selected for therapy using an FDA-approved companion diagnostic (CDx). Rucaparib was granted accelerated approval in 2020 for a similar indication.
November 26. Zotiraciclib – rHGG IDH1/IDH2. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the multi-kinase inhibitor for the treatment of patients with recurrent high-grade gliomas (rHGG) harbouring IDH1 or IDH2 mutations (IDHmut rHGG). These aggressive brain tumours have no established standard of care, limited treatment options, and poor prognoses.
December 16. Muzastotug + Pembrolizumab – CRC MSS. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the combination of muzastotug (anti–CTLA-4 IgG1 masked antibody) plus pembrolizumab (anti-PD-1 antobody) in microsatellite-stable metastatic colorectal cancer (MSS mCRC).
AIFA
December 4. Tislelizumab – NSCLC EGFR/ALK. The Italian Medicines Agency (AIFA) has authorized the anti-PD-1 monoclonal antibody,
- in combination with pemetrexed and platinum-containing chemotherapy, for the first-line treatment of adult patients with non-squamous non‑small‑cell lung cancer (NSCLC) whose tumours express PDL1 in ≥50% of tumour cells without positive EGFR or ALK mutation and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based radiochemotherapy, or metastatic NSCLC;
- as monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based chemotherapy. Patients with EGFR-mutated or ALK-positive NSCLC must also have received targeted therapies prior to receiving tislelizuma.
December 5. Vorasidenib – LGG IDH1/2. The Italian Medicines Agency (AIFA) has authorized the first-in-class dual isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma (subtypes of low-grade glioma, [LGG]) with an IDH1 R132 or IDH2 R172 mutation in adult and adolescent patients aged 12 years and older and weighing at least 40 kg who only had surgical intervention and who are not in immediate need of radiotherapy or chemotherapy.
December 16. Encorafenib – NSCLC BRAF. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new therapeutic indication of the selective BRAF V600E kinase inhibitor: encorafenib, in combination with binimetinib, is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring the BRAF V600E mutation.
December 16. Binimetinib – NSCLC BRAF. The Italian Medicines Agency (AIFA) has approved the reimbursement for the new therapeutic indication of the selective oral mitogen-activated protein kinase 1/2 (MEK 1/2) inhibitor: binimetinib, in combination with encorafenib, is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harbouring the BRAF V600E mutation.