AIFA
October 1 Camizestrant – BC ESR1. The Italian Medicines Agency (AIFA) has authorised the marketing of the selective estrogen receptor degrader (SERD) and estrogen receptor (ER) antagonist in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in the presence of an ESR1 mutation and in the absence of disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor.
October 14 Vorasidenib – LGG IDH1/2. The Italian Medicines Agency (AIFA)’s Board of Directors approved reimbursement eligibility for 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.
October 27 Gilteritinib – AML FLT3. The Italian Medicines Agency (AIFA) has approved the renegotiation of the inhibitor of the FLT3 receptor and AXL and ALK tyrosine kinases for the following therapeutic indications: gilteritinib is indicated as monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) who have a mutation in the FLT3 gene.
FDA
October 2 Pirtobrutinib – CLL/SLL 17p del. The U.S. Food and Drug Administration (FDA) has approved an additional indication for the non-covalent Bruton tyrosine kinase (BTK) inhibitor, for the first-line treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) with no known 17p deletion.
October 16 Pembrolizumab – Solid Tumors TMB. The U.S. Food and Drug Administration (FDA) granted traditional approval to the anti-programmed-death receptor-1 (anti-PD-1) monoclonal antibody and to pembrolizumab and berahyaluronidase alfa-pmph for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥13 mutations/megabase (mut/Mb)] solid tumors, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
October 19 Dostarlimab – LARC MSI. The U.S. Food and Drug Administration (FDA) granted accelerated approval to the PD-1-blocking antibody for the treatment of adult patients with Stage II/III locally advanced rectal cancer (LARC) that is microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA-authorized test for solid tumors.
October 26 Talazoparib – PC HRR. The U.S. Food and Drug Administration (FDA) has expanded approval of the oral poly ADP-ribose polymerase (PARP inhibitor) in combination with enzalutamide (an androgen receptor pathway inhibitor, ARPI) to the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC) with homologous recombination repair (HRR) gene mutations, including both BRCA and non-BRCA mutations.
October 1 TRE-515 – NSCLC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the deoxycytidine kinase (dCK) inhibitor in combination with KRAS inhibitors for the treatment of KRAS G12C mutation-positive non-small cell lung cancer (NSCLC) previously treated with an anti-PD-(L)1 antibody and platinum-based chemotherapy.
October 7 Telisotuzumab adizutecan – NSCLC EGFR. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the next-generation, c-Met protein-targeting antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor (Top1i) payload as a monotherapy for adult patients with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer (NSCLC) who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy.
October 15 Invikafusp alfa – solid tumors TMB. The U.S. Food and Drug Administration (FDA) has granted a second Fast Track Designation (FTD) to the bispecific dual T-cell agonist for the treatment of unresectable, locally advanced, or metastatic, tumor mutational burden high (TMB-H) solid tumors that have progressed following prior treatment including immune checkpoint inhibition and who have no satisfactory treatment options.
October 19 QTX3034 – CRC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the G12D-preferring multi-KRAS inhibitor for the treatment of patients with KRAS G12D-mutant colorectal cancer in combination with cetuximab, with or without FOLFOX chemotherapy.
October 26 Enzomenib (DSP-5336) – AML KMT2A. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the small molecule inhibitor of the menin and lysine (K)-specific methyltransferase 2A (KMT2A) protein interaction for the treatment of patients with relapsed/refractory acute leukemia with KMT2A rearrangement (R/R KMT2Ar).
The FDA previously granted Fast Track designation for enzomenib for the treatment of R/R acute myeloid leukemia with KMT2Ar or NPM1m in June 2024.