Hematemesis

Exelixis Provides Update on Phase 3 CONTACT-01 Trial Evaluating Cabozantinib in Combination with Atezolizumab in Patients with Metastatic Non-Small Cell Lung Cancer Previously Treated with Immunotherapy and Chemotherapy

Retrieved on: 
Thursday, December 8, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ClinicalTrials.gov, Hemoptysis, Proteinuria, Fatal, Recurrence, Hepatocellular carcinoma, Bleeding, Melena, Immunotherapy, PD-L1, Union, Docetaxel, Avascular necrosis, Hypertension, Takeda Pharmaceutical Company, Hematemesis, Fistula, AST, Patient, Pulmonary embolism, ULN, Grade 3, Nivolumab, ONJ, NSCLC, Lung cancer, Venous thrombosis, Sepsis, Post-vaccination embolic and thrombotic events, Roche, Progression-free survival, HIV disease progression rates, Embolism, Nephrotic syndrome, Incidence, ALT, EXEL, VEGFR, Tablet, Survival, History, Sorafenib, DTC, Abscess, HCC, Adrenal insufficiency, Hormone replacement therapy, Perforation, RCC, Ipsen, Risk, Medical imaging, Pharmaceutical industry, Exelixis, Jaw, Takeda

Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

Key Points: 
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX in combination with atezolizumab is not indicated as a treatment for NSCLC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.
  • Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Exelixis Announces Final Overall Survival Results from Phase 3 COSMIC-312 Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, March 14, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Research, Liver cancer, Risk, Tablet, DTC, VEGFR, Adrenal insufficiency, EXEL, OS, Union, Proteinuria, Embolism, New Drug Application, Takeda Pharmaceutical Company, Nephrotic syndrome, History, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Melena, ONJ, Hoffmann-La Roche, AST, ALT, Hypertension, Death, Nivolumab, Pulmonary embolism, Fistula, Bleeding, Recurrence, Sepsis, Patient, Perforation, RCC, Nasdaq, Sorafenib, Abscess, Fatal, Avascular necrosis, Hormone replacement therapy, Food, Cancer, Ipsen, Progression-free survival, ClinicalTrials.gov, Hematemesis, Drug discovery, Genentech, HCC, FDA, Adult, Medical Affairs Bureau, ULN, Grade 3, Venous thrombosis, Incidence, Hemoptysis, Post-vaccination embolic and thrombotic events, Pharmaceutical industry, Jaw, Exelixis, COSMIC-312, HCC, CABOMETYX, COSMIC-312, HCC, CABOMETYX

COSMIC-312 is a global, multicenter, randomized, controlled phase 3 trial that enrolled 837 patients at 281 study centers globally.

Key Points: 
  • COSMIC-312 is a global, multicenter, randomized, controlled phase 3 trial that enrolled 837 patients at 281 study centers globally.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX is not indicated as a treatment for previously untreated advanced HCC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.

Exelixis Announces Enrollment Completion in Phase 3 CONTACT-03 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Renal Cell Carcinoma

Retrieved on: 
Wednesday, January 5, 2022
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, ClinicalTrials.gov, MET, Renal cell carcinoma, Bleeding, Cancer, American Cancer Society, AXL, History, Neoplasm, Roche, ICI, Hormone replacement therapy, RCC, Sepsis, Hepatocellular carcinoma, AST, Avascular necrosis, Fistula, Hemoptysis, Hypertension, Progression-free survival, Hematemesis, Population, Takeda Pharmaceutical Company, Embolism, Union, Incidence, ULN, Proteinuria, Nasdaq, RECIST, Post-vaccination embolic and thrombotic events, Kidney cancer, Man, Sorafenib, DTC, Safety, Adrenal insufficiency, ONJ, Patient, HCC, Venous thrombosis, Protein, Perforation, Nephrotic syndrome, Fatal, Risk, Nivolumab, VEGF, Large-cell lung carcinoma, Growth, Tablet, Adult, ALT, Pulmonary embolism, Abscess, VEGFR, Woman, Melena, Grade 3, EXEL, Recurrence, Ipsen, Pharmaceutical industry, Medical imaging, Exelixis, Jaw, RCC, CABOMETYX, RCC, CABOMETYX

Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.

Key Points: 
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX in combination with atezolizumab is not indicated for metastatic RCC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • The von Hippel-Lindau tumor suppressor gene inhibits hepatocyte growth factor/scatter factor-induced invasion and branching morphogenesis in renal carcinoma cells.
  • Markedly increased amounts of messenger RNAs for vascular endothelial growth factor and placenta growth factor in renal cell carcinoma associated with angiogenesis.

Exelixis Announces Enrollment Completion in Phase 3 CONTACT-01 Pivotal Trial of Cabozantinib in Combination with an Immune Checkpoint Inhibitor in Previously Treated Metastatic Non-Small Cell Lung Cancer

Retrieved on: 
Tuesday, November 9, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Population, Venous thrombosis, Progression-free survival, Ipsen, Cancer, Lung cancer, Adenocarcinoma, ULN, Avascular necrosis, Squamous cell carcinoma, Sorafenib, Hypertension, Adrenal insufficiency, Takeda Pharmaceutical Company, Grade 3, Post-vaccination embolic and thrombotic events, Recurrence, VEGFR, European Union, Fistula, Disease, Roche, Hematemesis, Proteinuria, RCC, Abscess, Union, Perforation, Nivolumab, Hormone replacement therapy, Immunotherapy, Fatal, HIV disease progression rates, Sepsis, Bleeding, Hepatocellular carcinoma, Woman, Docetaxel, ALT, DTC, Incidence, AST, Hemoptysis, ClinicalTrials.gov, Large-cell lung carcinoma, Melena, History, ONJ, EXEL, NSCLC, Pulmonary embolism, Nephrotic syndrome, Tablet, HCC, Survival, Nasdaq, Patient, Risk, Embolism, Man, Adult, Pharmaceutical industry, Medical imaging, NSCLC, CABOMETYX, NSCLC, CABOMETYX

In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.

Key Points: 
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    CABOMETYX is not indicated as a treatment for metastatic NSCLC.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC, HCC, and DTC studies.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.

Mallinckrodt Presents Results on Real World Treatment Patterns and Outcomes in Hospitalized Patients with Esophageal Variceal Hemorrhage and Liver Cirrhosis Treated with Terlipressin at the American College of Gastroenterology Annual Scientific Meeting

Retrieved on: 
Monday, October 25, 2021
Death, Safety, Cochrane, Neurology, Hematemesis, Immunotherapy, Nephrology, Poster, Hospital, Rheumatology, Association, Bleeding, Esophagus, Analgesic, Royal Free Hospital, Cirrhosis, History, Evidence-based medicine, Patient, National Health Service, Investor relations, European Association for the Study of the Liver, Food, UCL Institute of Ophthalmology, SEC, Hypovolemia, Regulation of tobacco by the U.S. Food and Drug Administration, EVH, Terlipressin, University College London, Adult, Risk, Annual report, Ajman Specialty General Hospital, American College, U.S. Securities and Exchange Commission, Vein, Autoimmunity, Population, Ophthalmology, Intracellular digestion, Health insurance, Pharmaceutical industry, Medicine

Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration.

Key Points: 
  • Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration.
  • The retrospective medical chart review study assessed real world outcomes in 195 hospitalized adult patients across 18 hospitals in theU.K.
  • Nearly all patients (n=192; 98.5 percent) in the analysis were treated with terlipressin within a day of hospital admission and the mean treatment duration was 4.3 days.
  • This release includes forward-looking statements with regard to terlipressin, including its potential impact on patients.

Exelixis Announces Partner Takeda and Ono Receive Approval in Japan for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) for the Treatment of Unresectable or Metastatic Renal Cell Carcinoma

Retrieved on: 
Wednesday, August 25, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Sepsis, OS, Fatal, Protein, European Union, RCC, HCC, Venous thrombosis, ULN, Avascular necrosis, Grade 3, Bristol Myers Squibb, EXEL, Hypertension, Risk, Perforation, American Cancer Society, Checkmate, Woman, Nephrotic syndrome, VEGF, Union, Adrenal insufficiency, Embolism, ALT, Hormone replacement therapy, Hemoptysis, Man, ORR, History, Sale, Recurrence, Proteinuria, Bleeding, Incidence, Nasdaq, ONJ, Tablet, Takeda Pharmaceutical Company, Fistula, Sorafenib, AST, PFS, Abscess, Progression-free survival, AXL, Growth, Cancer, Hematemesis, Post-vaccination embolic and thrombotic events, Ipsen, Melena, MET, Patient, Pulmonary embolism, Kidney cancer, Nivolumab, Pharmaceutical industry, CheckMate -9ER, RCC, CABOMETYX® (cabozantinib), Exelixis, CHECKMATE -9ER, RCC, CABOMETYX® (CABOZANTINIB), EXELIXIS

The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients.

Key Points: 
  • The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the U.S. and Japan.
  • Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the U.S.
    Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Exelixis’ Partner Ipsen Receives Positive CHMP Opinion for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
Friday, February 26, 2021
Oncology, Health, FDA, General Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Clinical medicine, Drugs, Antineoplastic drugs, Bleeding, Orphan drugs, Cabozantinib, Quinolines, Sunitinib, Renal cell carcinoma, Hematemesis, Nivolumab

CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.

Key Points: 
  • CheckMate -9ER is an open-label, randomized (1:1), multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma with a clear cell component.
  • The primary efficacy analysis compares the doublet combination regimen of CABOMETYX and OPDIVO versus sunitinib in all randomized patients.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.
  • Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.