2019 in cancer

FDA · US: 116 records / 60 drugsHealth Canada · CA: 45 records / 25 drugsEMA · EU: 14 records / 13 drugs

• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmas monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast NeoplasmHER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmas adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast NeoplasmHER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Lung Non-Small Cell CarcinomaHER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic non-small…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmas monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmas monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast NeoplasmHER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Lung Non-Small Cell CarcinomaHER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic non-small…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast NeoplasmHER2-Positive Early Breast Cancer as neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmas monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast Neoplasmas adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast NeoplasmHER2-Low and HER2-Ultralow Metastatic Breast Cancer as monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application approved Malignant Breast NeoplasmHER2-Positive Metastatic Breast Cancer in combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive…openfda
• Dec 18, 2019Enfortumab Vedotin FDA · US original application approved Malignant Bladder Neoplasmin combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant…openfda
• Nov 14, 2019Zanubrutinib FDA · US original application approved Mantle Cell LymphomaMantle cell lymphoma (MCL) who have received at least one prior therapy.openfda
• Nov 14, 2019Zanubrutinib FDA · US original application accelerated approved Waldenstrom MacroglobulinemiaThis indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon…openfda
• Nov 14, 2019Zanubrutinib FDA · US original application approved Follicular LymphomaRelapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.openfda
• Nov 14, 2019Zanubrutinib FDA · US original application approved Marginal Zone LymphomaRelapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti–CD20-based regimen.openfda
• Nov 5, 2019Erlotinib Hydrochloride FDA · US original application approved Lung Non-Small Cell CarcinomaLimitations of Use: Safety and efficacy of erlotinib tablets have not been established in patients with NSCLC whose tumors have other EGFR mutations.openfda
• Nov 5, 2019Erlotinib Hydrochloride FDA · US original application approved Malignant Pancreatic NeoplasmFirst-line treatment of patients with locally advanced, unrespectable or metastatic pancreatic cancer, in combination with gemcitabine.openfda
• Nov 5, 2019Erlotinib Hydrochloride FDA · US original application approved Lung Non-Small Cell CarcinomaThe treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or…openfda
• Nov 1, 2019Palbociclib FDA · US original application approved Malignant Breast Neoplasmfor the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast…openfda
• Nov 1, 2019Palbociclib FDA · US original application approved Malignant Breast Neoplasmin combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive,…openfda
• Nov 1, 2019Palbociclib FDA · US original application approved Malignant Breast Neoplasmin combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative,…openfda
• Oct 3, 2019Dexamethasone FDA · US original application approved Multiple MyelomaHEMADY is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid…openfda
• Aug 19, 2019Fulvestrant FDA · US original application approved Malignant Breast NeoplasmMonotherapy CLIGAVYX is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced…openfda
• Aug 15, 2019Entrectinib 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
• Jul 30, 2019Darolutamide FDA · US original application approved Nonmetastatic Castration-Resistant Prostate CarcinomaNUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1…openfda
• Jul 3, 2019Selinexor FDA · US original application approved Multiple MyelomaIn combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapyopenfda
• Jul 3, 2019Selinexor FDA · US original application approved Multiple Myeloma. In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior…openfda
• Jun 10, 2019Polatuzumab Vedotin FDA · US original application approved Diffuse Large B-Cell Lymphomain combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory DLBCL, NOS, after at least two prior…openfda
• Jun 10, 2019Polatuzumab Vedotin FDA · US original application approved High Grade B-Cell Lymphomain combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously…openfda
• May 24, 2019Alpelisib FDA · US original application approved Malignant Breast NeoplasmPIQRAY is indicated in combination with fulvestrant for the treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2…openfda
• May 20, 2019Fulvestrant FDA · US original application approved Malignant Breast NeoplasmFulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor…openfda
• Apr 12, 2019Erdafitinib FDA · US original application approved Urothelial CarcinomaBALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic…openfda
• Jan 18, 2019Trastuzumab FDA · US original application approved Gastroesophageal Junction AdenocarcinomaThe treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.openfda
• Jan 18, 2019Trastuzumab FDA · US original application approved Malignant Breast NeoplasmThe treatment of HER2-overexpressing breast cancer.openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application accelerated approved tumor-agnosticHER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic…openfda
• Dec 20, 2019Trastuzumab Deruxtecan FDA · US original application accelerated approved tumor-agnosticHER2-Positive Locally Advanced or Metastatic Gastric Cancer as monotherapy for the treatment of adult patients with locally advanced or metastatic…openfda
• Dec 18, 2019Enfortumab Vedotin FDA · US original application approved cancer not stated in this recordhave previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or • are…openfda
• Nov 14, 2019Zanubrutinib FDA · US original application accelerated approved cancer not stated in this recordThis indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon…openfda
• Nov 5, 2019Erlotinib Hydrochloride FDA · US original application approved cancer not stated in this recordErlotinib tablets are not recommended for use in combination with platinum-based chemotherapy.openfda
• Nov 1, 2019Palbociclib FDA · US original application approved cancer not stated in this record; or o fulvestrant in patients with disease progression following endocrine therapy.openfda
• Aug 16, 2019Fedratinib FDA · US original application approved cancer not stated in this recordINREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential…openfda
• Aug 15, 2019Entrectinib 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
• Aug 2, 2019Pexidartinib FDA · US original application approved cancer not stated in this recordTURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional…openfda
• Mar 29, 2019Cladribine FDA · US original application approved cancer not stated in this recordMAVENCLAD is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive…openfda
• Mar 18, 2019Ceritinib FDA · US original application approved cancer not stated in this recordZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase…openfda
• Jan 18, 2019Trastuzumab FDA · US original application approved cancer not stated in this recordSelect patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ).openfda
• Nov 14, 2019Arsenic Trioxide EMA · EU centralised approved Acute Promyelocytic LeukemiaArsenic trioxide is indicated for induction of remission, and consolidation in adult patients with: Newly diagnosed low-to-intermediate risk acute…ema
• Oct 24, 2019Gilteritinib EMA · EU centralised approved Acute Myeloid LeukemiaXospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.ema
• May 6, 2019Lorlatinib EMA · EU centralised approved Lung Non-Small Cell CarcinomaLorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)?positive advanced non?small cell lung cancer…ema
• Jan 14, 2019Apalutamide EMA · EU centralised approved Nonmetastatic Castration-Resistant Prostate CarcinomaErleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing…ema
• Dec 27, 2019Olaparib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2019-12-27 (see label)openfda
• Dec 20, 2019Arsenic Trioxide Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as ARSENIC TRIOXIDE FOR INJECTION (DIN 02492768) under ATC L01XX27 ARSENIC TRIOXIDE. Indications are not published in the Drug Product…health-canada-dpd
• Dec 20, 2019Neratinib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as NERLYNX (DIN 02490536) under ATC L01EH02 NERATINIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Dec 19, 2019Pegfilgrastim EMA · EU centralised approved cancer not stated in this recordReduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with…ema
• Dec 18, 2019Cabazitaxel Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02487497) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug Product Database — see…health-canada-dpd
• Dec 18, 2019Cabazitaxel Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as CABAZITAXEL FOR INJECTION (DIN 02487500) under ATC L01CD04 CABAZITAXEL. Indications are not published in the Drug Product Database — see…health-canada-dpd

RegulatoryAll 2019 records with filters →

Studies

6,314

Interventional

4,888

Phase III

466

Industry-led

1,321

With posted results

869

Countries with sites

116

Published source: clinicaltrials · first_posted_date as posted