Post-vaccination embolic and thrombotic events

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

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

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

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

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.

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

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.

Statement from the Chief Public Health Officer of Canada on May 13, 2021

Retrieved on: 
Thursday, May 13, 2021

As the science and situation evolves, we are committed to providing timely, clear and evidence-informed guidance in order to keep everyone in Canada safe and healthy.

Key Points: 
  • As the science and situation evolves, we are committed to providing timely, clear and evidence-informed guidance in order to keep everyone in Canada safe and healthy.
  • Canada is continuing to monitor and assess reports of rare but serious medical events involving blood clots (thrombosis) with low levels of blood platelets (thrombocytopenia) (TTS) following immunization.
  • Based on available evidence to date, PHAC has estimated the rate of VITT in Canada as 1 in 83,000 doses administered.
  • At the same time, the Public Health Agency of Canada is providing Canadians with regular updates on COVID-19 vaccines administered , vaccination coverage and ongoing monitoring of vaccine safety across the country.

Johnson & Johnson Single-Shot COVID-19 Vaccinations to Resume in the U.S. for All Adults Aged 18 and Older Following CDC and FDA Decision

Retrieved on: 
Saturday, April 24, 2021

A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine.

Key Points: 
  • A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the Janssen COVID-19 Vaccine.
  • In people who developed these blood clots and low levels of platelets, symptoms began approximately one to two-weeks following vaccination.
  • Most people who developed these blood clots and low levels of platelets were females ages 18 through 49 years.
  • You should seek medical attention right away if you have any of the following symptoms after receiving Janssen COVID-19 Vaccine:\n'