AIFA
July 21 Tovorafenib – LGG BRAF. The Italian Medicines Agency (AIFA) has authorised the marketing of the Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases as monotherapy for the treatment of patients 6 months of age and older with paediatric low-grade-glioma (LGG) harbouring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
July 29 Inavolisib – BC PIK3CA. The Italian Medicines Agency (AIFA)’s Board of Directors approved reimbursement eligibility for the mutant-selective PI3Kα inhibitor, in combination with palbociclib and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.
June 9 Blinatumomab – ALL BCR-ABL. The Italian Medicines Agency (AIFA)’s Board of Directors approved reimbursement eligibility for three extensions of indication for the specialized bispecific T-cell engager (BiTE) antibody construct used to treat B-cell acute lymphoblastic leukemia (ALL). Blinatumomab is indicated as part of consolidation therapy for the treatment of adult patients with newly diagnosed CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (ALL) who test negative for minimal residual disease (MRD) following the induction phase.
Blinatumomab is indicated as monotherapy for the treatment of paediatric patients aged 1 month or older with high-risk, first-relapse, CD19-positive, Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukaemia (ALL), as part of consolidation therapy.
EMA
July 15 Cetuximab – CRC BRAF. The European Commission (EC) has approved the extension of indication for the Anti-EGFR monoclonal antibody to include cetuximab in combination with encorafenib and mFOLFOX6 for the treatment of metastatic colorectal cancer with a BRAF V600E
July 1 Encorafenib – CRC BRAF. The European Commission (EC) has approved the extension of indication for the BRAF kinase inhibitor to include encorafenib, in combination with cetuximab and FOLFOX, for the first line treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation
September 16 Alpelisib – BC PIK3CA. The European Commission (EC) has approved the extension of indication for the PI3K inhibitor in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen.
CHMP (Committee for Medicinal Products for Human Use – EMA)
July 23. Alpelisib – BC PIK3CA. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the extension/change of therapeutic indications so that the phosphatidylinositol 3-kinase (PI3K) inhibitor is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following an endocrine-based regimen.
September 17 Ensartinib – NSCLC ALK. 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 ALK kinase inhibitor, intended for the treatment of adults with anaplastic lymphoma kinase (ALK)-positive, advanced non-small cell lung cancer (NSCLC).
FDA
July 14 Selpercatinib – Solid Tumors RET. The U.S. Food and Drug Administration (FDA) granted traditional approval to the RET receptor tyrosine kinase inhibitor for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
July 14 Gedatolisib – BC PIK3CA. The U.S. Food and Drug Administration (FDA) approved the pan-PI3K and mTORC1/2 kinase inhibitor in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected, following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
July 22 Zidesamtinib – NSCLC ROS1. The U.S. Food and Drug Administration (FDA) approved the ROS1 kinase inhibitor for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI). Zidesamtinib retains activity in cells carrying the common ROS1 resistance mutations and showed antitumor activity in an intracranial model.
September 4 Camizestrant – BC ESR1. The U.S. Food and Drug Administration (FDA) granted accelerated approval to 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 adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.
September 9 Sevabertinib – NSCLC HER2. The U.S. Food and Drug Administration (FDA) granted accelerated approval to the HER2 kinase inhibitor for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumours have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. This approval expands the existing indication for sevabertinib, which was previously granted accelerated approval for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations who had received prior systemic therapy.
September 18 Imlunestrant – BC ESR1. The U.S. Food and Drug Administration (FDA) approved the selective estrogen receptor antagonist and degrader, in combination with abemaciclib, for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.
September 23 Lirafugratinib – CAA FGFR2. The U.S. Food and Drug Administration (FDA) approved the FGFR2 kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harbouring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement.
June 3 TER-2013 – BC AKT/PI3K/PTEN. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for the AKT1-selective inhibitor, in patients with locally advanced, unresectable or metastatic HR+/HER2- breast cancer harbouring one or more AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease.
June 3 VS-7375 – NSCLC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the investigational selective KRAS G12D (ON/OFF) inhibitor, for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer.
July 23 Talazoparib – mHSPC HRR. The U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for the oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), in men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC).
August 3 Olomorasib PC KRAS. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational, next-generation inhibitor of KRAS G12C as a monotherapy for the treatment of adult patients with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation, as determined by an FDA-approved test.
August 17 Sapanisertib and Serabelisib EC PI3K/AKT/mTOR The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of a selective PI3K-alpha inhibitor (serabelisib) and mTORC1/mTORC2 inhibitor (sapanisertib) with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumours harbour a PI3K/AKT/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).
August 18 ETX-19477 BC BRCA. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the PARG inhibitor for the treatment of adult patients with BRCA-mutated, hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), unresectable or metastatic breast cancer.
August 18 BH-30643 NSCLC EGFR. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigational OMNI-EGFR inhibitor for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer (NSCLC) after prior treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI).
August 20 Safusidenib Glioma IDH1. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the investigational selective inhibitor of mutant IDH1 for the treatment of IDH1-mutant glioma.
August 20 Dostarlimab – RC MSI. The U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for the PD-1-blocking antibody for the treatment of patients with previously untreated stage II and III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer.
August 24 ERAS-0015 – PDAC KRAS. The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to the pan-RAS molecular glue for the treatment of patients with metastatic KRAS G12X-positive pancreatic ductal adenocarcinoma (PDAC).
September 14 daraxonrasib – PDAC RAS. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to the RAS(ON) multi-selective inhibitor, for treatment-naïve RAS mutant metastatic pancreatic adenocarcinoma (PDAC) in combination with gemcitabine and nab-paclitaxel (GnP).
September 29 Plinabulin – NSCLC AGAs. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to and docetaxel for the treatment of patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGAs) whose disease has progressed following prior anti-PD-(L)1 antibody therapy and platinum-based chemotherapy, representing patients in the second- or third-line treatment setting.