Sunitinib

Exelixis Announces Consistent Efficacy Benefits Across Subgroups of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-line Treatment for Patients with Advanced Renal Cell Carcinoma

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fredag, juni 4, 2021
General Health, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Clinical medicine, Drugs, Hematology, Orphan drugs, Antineoplastic drugs, Cabozantinib, Cyclopropanes, Sunitinib, Renal cell carcinoma, Venous thrombosis, Embolism, CheckMate -9ER, RCC, CABOMETYX® (cabozantinib), Exelixis, CHECKMATE -9ER, RCC, CABOMETYX® (CABOZANTINIB), EXELIXIS

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.
  • Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients.

Exelixis Announces Quality-Adjusted Survival Benefit Demonstrated in Analysis of Phase 3 CheckMate -9ER Trial of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) in Patients with Previously Untreated Advanced Renal Cell Carcinoma

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fredag, juni 4, 2021
General Health, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Drugs, Cancer treatments, Antineoplastic drugs, Orphan drugs, Cabozantinib, Cyclopropanes, Quinolines, Sunitinib, Renal cell carcinoma, Nivolumab, Toni Choueiri, CheckMate -9ER, RCC, CABOMETYX® (cabozantinib), Exelixis, CHECKMATE -9ER, RCC, CABOMETYX® (CABOZANTINIB), EXELIXIS

This analysis shows that the overall survival benefit demonstrated in the phase 3 CheckMate -9ER trial results in clinically important gains in quality-adjusted survival.

Key Points: 
  • This analysis shows that the overall survival benefit demonstrated in the phase 3 CheckMate -9ER trial results in clinically important gains in quality-adjusted survival.
  • 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.

Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications

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fredag, maj 7, 2021
Cancer treatments, Clinical medicine, Drugs, Orphan drugs, Antineoplastic drugs, Breakthrough therapy, Indoles, Pyrroles, Sunitinib, Pembrolizumab, Society of Gynecologic Oncology, SGO

These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data.

Key Points: 
  • These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data.
  • "We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of KEYTRUDA plus LENVIMA in these patients by granting priority review for these applications.
  • "\nThe applications in advanced RCC are based on results from the CLEAR study (Study 307/KEYNOTE-581), in which LENVIMA plus KEYTRUDA demonstrated statistically significant improvements in PFS, OS and ORR versus sunitinib.
  • These data were presented in March at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women\'s Cancer.

Eisai: Application Submitted for Additional Indication of Anti Cancer Agent Lenvima in Combination With Keytruda as a Treatment for Advanced Renal Cell Carcinoma in Japan

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onsdag, mars 31, 2021
Cancer treatments, Health sciences, Medicine, Clinical trials, Medical statistics, Medical terminology, Orphan drugs, Antineoplastic drugs, Sunitinib, Clinical endpoint, Progression-free survival, Survival rate

TOKYO, Mar 31, 2021 - (JCN Newswire) - Eisai Co., Ltd. and MSD K.K.

Key Points: 
  • TOKYO, Mar 31, 2021 - (JCN Newswire) - Eisai Co., Ltd. and MSD K.K.
  • This is the first application to be submitted in Japan for this combination therapy.
  • In this trial, LENVIMA plus KEYTRUDA demonstrated statistically significant and clinically meaningful improvements in the primary endpoint of progression-free survival (PFS) as well as key secondary endpoints of overall survival (OS) and objective response rate (ORR) versus sunitinib.
  • The safety profile of LENVIMA plus KEYTRUDA was consistent with previously reported studies.

Exelixis’ Partner Ipsen Receives European Commission Approval for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

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onsdag, mars 31, 2021
Oncology, Health, FDA, Other Health, General Health, Pharmaceutical, Biotechnology, Chemical compounds, Drugs, Antineoplastic drugs, Cancer treatments, Cabozantinib, Cyclopropanes, Quinolines, Ipsen, Nivolumab, Sunitinib, Renal cell carcinoma, Exelixis

Exelixis, Inc. (Nasdaq: EXEL) today announced its partner Ipsen received approval from the European Commission (EC) for CABOMETYX (cabozantinib) in combination with OPDIVO (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced its partner Ipsen received approval from the European Commission (EC) for CABOMETYX (cabozantinib) in combination with OPDIVO (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC).
  • 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.

Ipsen Receives Positive CHMP Opinion Recommending Cabometyx® in Combination With Opdivo® as First-line Treatment for Patients Living With Advanced Renal Cell Carcinoma

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fredag, februari 26, 2021
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Chemical compounds, Drugs, Cancer treatments, Antineoplastic drugs, Orphan drugs, Breakthrough therapy, Bristol-Myers Squibb, Cabozantinib, Nivolumab, Sunitinib, Renal cell carcinoma, Toni Choueiri

Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world.

Key Points: 
  • Advanced renal cell carcinoma is a disease that significantly impacts the lives of people around the world.
  • The combination of Cabometyx and Opdivo was approved by the U.S. Food and Drug Administration (FDA) as first-line treatment for patients living with advanced renal cell carcinoma in January 2021.
  • The positive CHMP opinion brings us one step closer to the promise of a new approach that combines improved treatment outcomes, a favorable tolerability profile and superior health-related quality of life for patients.
  • Nivolumab + cabozantinib vs sunitinib in first-line treatment for advanced renal cell carcinoma: First results from the randomized phase III CheckMate 9ER trial.

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: 
fredag, februari 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.

Exelixis Highlights Positive Results for CABOMETYX® (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU

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lördag, februari 13, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Bristol-Myers Squibb, Clinical medicine, Drugs, Medicine, Antineoplastic drugs, Breakthrough therapy, Ipilimumab, Renal cell carcinoma, Sunitinib, Nivolumab, Papillary renal cell carcinoma, the SWOG S1500 Clinical Trial, Papillary Renal Cell Carcinoma, CABOMETYX® (cabozantinib), Exelixis

Its gratifying to see these positive results of the PAPMET trial, which may help physicians choose an appropriate therapy for their patients with advanced papillary renal cell carcinoma.

Key Points: 
  • Its gratifying to see these positive results of the PAPMET trial, which may help physicians choose an appropriate therapy for their patients with advanced papillary renal cell carcinoma.
  • The discontinuation rate of study medications due to treatment-related adverse events was 24% for sunitinib and 23% for CABOMETYX.
  • The most common grade 3 or 4 adverse events with CABOMETYX were hypertension (32%), hand-foot syndrome (20%) and fatigue (13%).
  • Prior therapy was received by 10 patients (7%), and the most common prior therapy was the combination of nivolumab with ipilimumab (4 patients).

Ipsen: New Data From Pivotal Phase III CheckMate -9ER trial of Cabometyx® in Combination with Opdivo® Showed Significantly Improved QoL Benefits and Sustained Superior Efficacy Versus sunitinib in Patients Living with aRCC

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måndag, februari 8, 2021
Research, Hospitals, Clinical trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, Chemical compounds, Health sciences, Companies, Antineoplastic drugs, Exelixis, Cabozantinib, Ipsen, Bristol Myers Squibb, Sunitinib, Ono Pharmaceutical, Pharmaceutical industry

The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients.

Key Points: 
  • The primary efficacy analysis is comparing the doublet combination versus sunitinib in all randomized patients.
  • The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.
  • Ipsen has exclusive rights for the commercialization and further clinical development of Cabometyx outside of the U.S. and Japan.
  • Cabometyx is a registered trademark of Exelixis, Inc.
    Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care.

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) as a First-Line Treatment for Patients with Advanced Renal Cell Carcinoma

Retrieved on: 
fredag, januari 22, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Drugs, Cancer treatments, Antineoplastic drugs, Orphan drugs, Breakthrough therapy, Bristol-Myers Squibb, Cabozantinib, Nivolumab, Sunitinib, Renal cell carcinoma, Exelixis, CheckMate -9ER, RCC, CABOMETYX® (cabozantinib), Exelixis

Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO (nivolumab).

Key Points: 
  • Exelixis, Inc. (NASDAQ: EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) for patients with advanced renal cell carcinoma (RCC) as a first-line treatment in combination with OPDIVO (nivolumab).
  • The findings for the combination of CABOMETYX and OPDIVO in the CheckMate -9ER trial make the FDA approval of this combination a notable development for the patient community.
  • 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.