2024 in cancer

FDA · US: 133 records / 65 drugsHealth Canada · CA: 49 records / 27 drugsEMA · EU: 32 records / 25 drugs

• Nov 22, 2024Imatinib FDA · US original application approved Acute Lymphoblastic LeukemiaPediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.openfda
• Nov 22, 2024Imatinib FDA · US original application approved Acute Lymphoblastic LeukemiaAdult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).openfda
• Nov 22, 2024Imatinib FDA · US original application approved Aggressive Systemic MastocytosisAdult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.openfda
• Nov 22, 2024Imatinib FDA · US original application approved Chronic Eosinophilic Leukemia, Not Otherwise SpecifiedAdult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis…openfda
• Nov 22, 2024Imatinib FDA · US original application approved Malignant Gastrointestinal Stromal TumorPatients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).openfda
• Nov 22, 2024Imatinib FDA · US original application approved Myelodysplastic/Myeloproliferative NeoplasmAdult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.openfda
• Nov 20, 2024Zanidatamab FDA · US original application approved Malignant Biliary Tract NeoplasmBiliary Tract Cancer (BTC) • for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC, as detected by an…openfda
• Nov 20, 2024Zanidatamab FDA · US original application approved Esophageal Adenocarcinomain combination with fluoropyrimidine- and platinum-containing chemotherapy, as first-line treatment of adult patients with HER2-positive (IHC 3+) unresectable…openfda
• Nov 20, 2024Zanidatamab FDA · US original application approved Esophageal AdenocarcinomaGastroesophageal Adenocarcinoma (GEA) • in combination with fluoropyrimidine- and platinum-containing chemotherapy, and tislelizumab-jsgr, as first-line…openfda
• Nov 15, 2024Revumenib FDA · US original application approved Acute Myeloid LeukemiaREVUFORJ is a menin inhibitor indicated for: the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene ( KMT2A )…openfda
• Nov 7, 2024Nilotinib FDA · US original application approved Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 PositiveAdult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.openfda
• Oct 23, 2024Docetaxel FDA · US original application approved Castration-Resistant Prostate CarcinomaCastration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate canceropenfda
• Oct 23, 2024Docetaxel FDA · US original application approved Malignant Breast NeoplasmBreast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant…openfda
• Oct 23, 2024Docetaxel FDA · US original application approved Gastric AdenocarcinomaGastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junctionopenfda
• Oct 23, 2024Docetaxel FDA · US original application approved Lung Non-Small Cell CarcinomaNon-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable,…openfda
• Oct 23, 2024Docetaxel FDA · US original application approved Head and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHNopenfda
• Oct 18, 2024Zolbetuximab FDA · US original application approved Gastroesophageal Junction AdenocarcinomaVYLOY, in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adults with locally advanced…openfda
• Oct 10, 2024Inavolisib FDA · US original application approved Malignant Breast NeoplasmITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor…openfda
• Aug 26, 2024Bortezomib FDA · US original application approved Multiple Myelomatreatment of adult patients with multiple myelomaopenfda
• Aug 26, 2024Bortezomib FDA · US original application approved Mantle Cell Lymphomatreatment of adult patients with mantle cell lymphomaopenfda
• Aug 19, 2024Lazertinib FDA · US original application approved Lung Non-Small Cell CarcinomaLAZCLUZE, in combination with amivantamab, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung…openfda
• Aug 6, 2024Vorasidenib FDA · US original application approved Grade 2 Follicular LymphomaVORANIGO is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible…openfda
• Jun 28, 2024Pemetrexed FDA · US original application approved Pleural Malignant Mesotheliomainitial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not…openfda
• Jun 28, 2024Pemetrexed FDA · US original application approved Lung Non-Small Cell CarcinomaLimitations of Use: AXTLE is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.openfda
• Jun 28, 2024Pemetrexed FDA · US original application approved Lung Non-Squamous Non-Small Cell Carcinomaas a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.openfda
• Jun 28, 2024Pemetrexed FDA · US original application approved Lung Non-Squamous Non-Small Cell Carcinomain combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer…openfda
• Jun 28, 2024Pemetrexed FDA · US original application approved Lung Non-Squamous Non-Small Cell Carcinomaas a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four…openfda
• Jun 28, 2024Pemetrexed FDA · US original application approved Lung Non-Squamous Non-Small Cell Carcinomain combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC.openfda
• Jun 25, 2024Thiotepa FDA · US original application approved Breast AdenocarcinomaTEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary.openfda
• May 16, 2024Tarlatamab FDA · US original application approved Lung Small Cell CarcinomaIMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after…openfda
• Apr 22, 2024Nogapendekin Alfa Inbakicept FDA · US original application approved Non-Muscle Invasive Bladder CarcinomaANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive nonmuscle invasive bladder…openfda
• Apr 10, 2024Selpercatinib FDA · US original application approved Thyroid Gland Medullary CarcinomaAdult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an…openfda
• Apr 10, 2024Selpercatinib FDA · US original application approved Lung Non-Small Cell CarcinomaAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by…openfda
• Apr 10, 2024Selpercatinib FDA · US original application approved Malignant Thyroid Gland NeoplasmAdult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test,…openfda
• Mar 13, 2024Tislelizumab FDA · US original application approved Esophageal AdenocarcinomaGastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma in combination with zanidatamab-hrii and fluoropyrimidine- and platinum-containing…openfda
• Mar 13, 2024Tislelizumab FDA · US original application approved Esophageal Squamous Cell Carcinomaas a single agent in adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a…openfda
• Mar 13, 2024Tislelizumab FDA · US original application approved Esophageal Squamous Cell CarcinomaEsophageal Cancer in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal…openfda
• Mar 7, 2024Talazoparib FDA · US original application approved Castration-Resistant Prostate CarcinomaHRR Gene-Mutated mCRPC • In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate…openfda
• Mar 7, 2024Talazoparib FDA · US original application approved Malignant Breast NeoplasmBreast Cancer • As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m)…openfda
• Mar 5, 2024Denosumab FDA · US original application approved Malignant Breast Neoplasmto increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.openfda
• Mar 5, 2024Denosumab FDA · US original application approved Malignant Prostate Neoplasmto increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.openfda
• Dec 23, 2024Hydroxyurea FDA · US original application approved cancer not stated in this recordXROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older…openfda
• Dec 18, 2024Ensartinib FDA · US original application approved cancer not stated in this recordENSACOVE is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung…openfda
• Nov 22, 2024Imatinib FDA · US original application approved cancer not stated in this recordNewly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. • Patients with…openfda
• Nov 20, 2024Zanidatamab FDA · US original application accelerated approved cancer not stated in this record*This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be…openfda
• Nov 7, 2024Nilotinib FDA · US original application approved cancer not stated in this recordAdult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.openfda
• Apr 24, 2024Alpelisib FDA · US original application accelerated approved cancer not stated in this recordVIJOICE is indicated for the treatment of adult and pediatric patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth…openfda
• Apr 23, 2024Tovorafenib FDA · US original application accelerated approved cancer not stated in this recordOJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF…openfda
• Apr 23, 2024Tovorafenib FDA · US original application accelerated approved cancer not stated in this recordOJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF…openfda
• Apr 10, 2024Selpercatinib FDA · US original application approved tumor-agnosticAdult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved…openfda
• Apr 4, 2024Hydroxyurea FDA · US original application approved cancer not stated in this recordXROMI is indicated to reduce the frequency of painful crises and reduce the need for blood transfusions in pediatric patients aged 6 months of age and older…openfda
• Mar 13, 2024Tislelizumab FDA · US original application approved cancer not stated in this recordGastric Cancer in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic…openfda
• Mar 5, 2024Denosumab FDA · US original application approved cancer not stated in this recordof postmenopausal women with osteoporosis at high risk for fracture. • to increase bone mass in men with osteoporosis at high risk for fracture. • of…openfda
• Nov 14, 2024Pomalidomide EMA · EU centralised approved Multiple MyelomaPomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at…ema
• Nov 14, 2024Mirvetuximab Soravtansine EMA · EU centralised approved Malignant Peritoneal NeoplasmElahere as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous…ema
• Sep 19, 2024Axitinib EMA · EU centralised approved Renal Cell CarcinomaAxitinib Accord is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a…ema
• Aug 22, 2024Enzalutamide EMA · EU centralised approved Castration-Resistant Prostate CarcinomaEnzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk…ema
• Aug 22, 2024Nilotinib EMA · EU centralised approved Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 PositiveNilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous…ema
• Aug 22, 2024Erdafitinib EMA · EU centralised approved Urothelial CarcinomaBalversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible…ema
• Jul 26, 2024Pomalidomide EMA · EU centralised approved Multiple MyelomaPomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at…ema

RegulatoryAll 2024 records with filters →

Studies

8,875

Interventional

6,378

Phase III

569

Industry-led

1,708

With posted results

92

Countries with sites

111

Published source: clinicaltrials · first_posted_date as posted