2023 in cancer

FDA · US: 151 records / 62 drugsHealth Canada · CA: 51 records / 29 drugsEMA · EU: 18 records / 18 drugs

• Nov 16, 2023Capivasertib FDA · US original application approved Malignant Breast NeoplasmHR positive, HER2 negative locally advanced or metastatic breast cancer • in combination with fulvestrant for the treatment of adult patients with hormone…openfda
• Nov 16, 2023Capivasertib FDA · US original application approved Malignant Prostate NeoplasmPTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer • in combination with abiraterone and prednisone for the…openfda
• Nov 15, 2023Repotrectinib FDA · US original application approved ROS1-Positive Lung Non-Small Cell CarcinomaAUGTYRO is a kinase inhibitor indicated for the treatment of • adult patients with locally advanced or metastatic ROS1- positive non-small cell lung cancer…openfda
• Nov 8, 2023Fruquintinib FDA · US original application approved Malignant Colorectal Neoplasm1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated…openfda
• Oct 27, 2023Toripalimab FDA · US original application approved Nasopharyngeal Carcinomain combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma…openfda
• Oct 20, 2023Entrectinib FDA · US original application approved Lung Non-Small Cell CarcinomaAdult patients with ROS1- positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.openfda
• Sep 26, 2023Bosutinib FDA · US original application approved Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positiveadult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to…openfda
• Sep 12, 2023Cyclophosphamide FDA · US original application approved Mycosis Fungoidesmycosis fungoides (advanced disease)openfda
• Sep 12, 2023Cyclophosphamide FDA · US original application approved Retinoblastomaretinoblastomaopenfda
• Sep 12, 2023Cyclophosphamide FDA · US original application approved Neuroblastomaneuroblastoma (disseminated disease)openfda
• Sep 12, 2023Cyclophosphamide FDA · US original application approved Multiple Myelomamultiple myelomaopenfda
• Sep 12, 2023Cyclophosphamide FDA · US original application approved Ovarian Adenocarcinomaadenocarcinoma of the ovaryopenfda
• Sep 7, 2023Crizotinib FDA · US original application approved Anaplastic Large Cell Lymphomao Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. •…openfda
• Sep 7, 2023Crizotinib FDA · US original application approved Anaplastic Large Cell Lymphomapediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.openfda
• Aug 18, 2023Melphalan FDA · US original application approved Multiple MyelomaMultiple Myeloma-Palliative Treatment IVRA is indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not…openfda
• Aug 14, 2023Elranatamab FDA · US original application accelerated approved Multiple MyelomaELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy,…openfda
• Aug 9, 2023Talquetamab FDA · US original application accelerated approved Multiple MyelomaTALVEY is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy,…openfda
• Jul 20, 2023Quizartinib FDA · US original application approved Acute Myeloid LeukemiaVANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy…openfda
• May 22, 2023Pemetrexed 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
• May 22, 2023Pemetrexed FDA · US original application approved Lung Non-Small Cell CarcinomaLimitations of Use: PEMRYDI RTU is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer.openfda
• May 22, 2023Pemetrexed 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
• May 22, 2023Pemetrexed 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
• May 22, 2023Pemetrexed 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
• May 22, 2023Pemetrexed 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
• May 19, 2023Epcoritamab FDA · US original application accelerated approved Follicular LymphomaThis indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be…openfda
• May 11, 2023Paclitaxel FDA · US original application approved Lung Non-Small Cell CarcinomaLocally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates…openfda
• May 11, 2023Paclitaxel FDA · US original application approved Malignant Breast NeoplasmMetastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy…openfda
• May 11, 2023Paclitaxel FDA · US original application approved Pancreatic AdenocarcinomaMetastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine.openfda
• Apr 26, 2023Niraparib FDA · US original application approved Malignant Peritoneal Neoplasmfor the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated recurrent epithelial ovarian, fallopian tube,…openfda
• Apr 26, 2023Niraparib FDA · US original application approved Malignant Peritoneal Neoplasmfor the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial…openfda
• Mar 22, 2023Retifanlimab FDA · US original application approved Merkel Cell CarcinomaMerkel Cell Carcinoma (MCC) for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).openfda
• Mar 16, 2023Dabrafenib FDA · US original application approved MelanomaTAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as…openfda
• Mar 16, 2023Trametinib FDA · US original application approved Thyroid Gland Anaplastic Carcinomathe treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test,…openfda
• Mar 16, 2023Trametinib FDA · US original application approved Malignant Colorectal NeoplasmLimitations of Use : MEKINIST is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.openfda
• Mar 16, 2023Trametinib FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.openfda
• Mar 16, 2023Trametinib FDA · US original application approved Melanomathe adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s),…openfda
• Mar 16, 2023Trametinib FDA · US original application approved MelanomaMEKINIST is indicated, in combination with dabrafenib, for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K…openfda
• Mar 16, 2023Trametinib FDA · US original application approved MelanomaMEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic…openfda
• Mar 16, 2023Dabrafenib FDA · US original application approved Thyroid Gland Anaplastic Carcinomathe treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation, as detected by an FDA-approved test,…openfda
• Mar 16, 2023Dabrafenib FDA · US original application approved Lung Non-Small Cell Carcinomathe treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.openfda
• Mar 16, 2023Dabrafenib FDA · US original application approved Melanomathe adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s),…openfda
• Mar 16, 2023Dabrafenib FDA · US original application approved MelanomaTAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K…openfda
• Mar 16, 2023Dabrafenib FDA · US original application approved Malignant Colorectal NeoplasmLimitations of Use : TAFINLAR is not indicated for treatment of patients with colorectal cancer because of known intrinsic resistance to BRAF inhibition.openfda
• Jan 27, 2023Pirtobrutinib FDA · US original application approved Mantle Cell LymphomaAdult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.openfda
• Jan 27, 2023Pirtobrutinib FDA · US original application accelerated approved Chronic Lymphocytic Leukemia. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and…openfda
• Jan 27, 2023Elacestrant FDA · US original application approved Malignant Breast NeoplasmORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2…openfda
• Dec 15, 2023Roflumilast FDA · US original application approved cancer not stated in this recordZORYVE topical foam, 0.3%, is a phosphodiesterase 4 inhibitor indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of…openfda
• Dec 5, 2023Dasatinib FDA · US original application approved cancer not stated in this record1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid…openfda
• Nov 27, 2023Nirogacestat FDA · US original application approved cancer not stated in this recordOGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for…openfda
• Nov 15, 2023Repotrectinib FDA · US original application accelerated approved tumor-agnosticadult and pediatric patients 12 years of age and older with solid tumors that: • have a neurotrophic tyrosine receptor kinase ( NTRK ) gene fusion and • are…openfda
• Oct 27, 2023Toripalimab FDA · US original application approved cancer not stated in this recordas a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing…openfda
• Oct 20, 2023Entrectinib FDA · US original application accelerated approved tumor-agnosticAdult and pediatric patients older than 1 month of age with solid tumors that: have a neurotrophic tyrosine receptor kinase ( NTRK) gene fusion, as detected by…openfda
• Sep 26, 2023Bosutinib FDA · US original application approved cancer not stated in this recordAdult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML),…openfda
• Sep 15, 2023Momelotinib FDA · US original application approved cancer not stated in this recordOJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and…openfda
• Sep 12, 2023Cyclophosphamide FDA · US original application approved cancer not stated in this recordmalignant lymphomas (Stages III and IV of the Ann Arbor staging system), Hodgkin’s lymphoma, lymphocytic lymphoma (nodular or diffuse), mixed-cell type…openfda
• Sep 7, 2023Crizotinib FDA · US original application approved cancer not stated in this recordXALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic…openfda
• Aug 18, 2023Aflibercept FDA · US original application approved cancer not stated in this recordEYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular…openfda
• Jun 15, 2023Glofitamab FDA · US original application accelerated approved cancer not stated in this recordCOLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or…openfda
• Jun 7, 2023Cyclophosphamide FDA · US original application approved cancer not stated in this recordMalignant Diseases FRINDOVYX is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of the Ann Arbor…openfda
• May 19, 2023Epcoritamab FDA · US original application approved cancer not stated in this recordFor the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from…openfda

RegulatoryAll 2023 records with filters →

Studies

7,898

Interventional

5,730

Phase III

501

Industry-led

1,632

With posted results

198

Countries with sites

115

Published source: clinicaltrials · first_posted_date as posted