Specialty Pharma Journal Specialty, Precision & Technology
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Inlyta® (axitinib), Pfizer’s tyrosine kinase inhibitor, met both primary endpoints of overall survival (OS) and progression-free survival (PFS) in the …
Tag Archives: Renal Cell Carcinoma
October, 2018
June, 2018
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1 June
Opdivo Plus Yervoy Improved Health-Related Quality of Life in Intermediate- and Poor-Risk Patients with Advanced Kidney Cancer
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced patient-reported outcomes data from the Phase 3 CheckMate -214 trial in intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC) treated with the Immuno-Oncology combination Opdivo (nivolumab) plus low-dose (1mg/kg) Yervoy (ipilimumab) versus sunitinib over a two-year follow-up period. Patients in the study treated with Opdivo plus low-dose Yervoy reported …
April, 2018
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20 April
Argos Discontinues Late-Stage Trial of Investigational Vaccine for Patients with Metastatic Renal Cell Carcinoma
DURHAM, N.C., April 19, 2018 (GLOBE NEWSWIRE) — Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis® precision immunotherapy technology platform, today reported interim results from its randomized, active controlled, open-label, multi-center Phase 3 ADAPT trial of Rocapuldencel-T in …
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16 April
FDA Approves Opdivo + Yervoy Combination as First-Line Treatment for Patients with Advanced Renal Cell Carcinoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced that Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).1,2 In the Phase 3 …
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11 April
Pfizer Stops Late-Stage Trial in Renal Cell Carcinoma After it Fails to Demonstrate An Improvement in Disease-Free Survival
Pfizer Inc. today announced that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating INLYTA® (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility. The recommendation was …
January, 2018
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9 January
FDA Grants Breakthrough Therapy Designation to Eisai and Merck’s Kidney Cancer Combo Therapy
TOKYO and KENILWORTH, N.J., Jan. 9, 2018 /PRNewswire/ — Eisai Co., Ltd. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai’s multiple receptor tyrosine kinase inhibitor LENVIMA® (lenvatinib) …
December, 2017
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21 December
FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with Inlyta in Advanced Renal Cell Carcinoma
DARMSTADT, Germany and NEW YORK, December 21, 2017 /PRNewswire/ — Second Breakthrough Therapy Designation for avelumab in hard-to-treat cancer Renal cell carcinoma, the most common form of kidney cancer, has a poor prognosis in advanced stage[1],[2] Javelin Renal clinical development program is ongoing, including Phase III first-line study Merck and …
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20 December
FDA Expands Approval of Exelixis’ Cabometyx for Previously Untreated Advanced Renal Cell Carcinoma
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). RCC is the most common form of kidney cancer in adults. The FDA’s priority review and approval of CABOMETYX …
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15 December
FDA Grants Priority Review to the sBLA for Opdivo Plus Yervoy for the Treatment of Advanced Renal Cell Carcinoma
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for priority review of Opdivo (nivolumab) plus Yervoy (ipilimumab) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma (RCC). The FDA also previously granted Breakthrough Therapy Designation for …
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11 December
Genentech’s Tecentriq and Avastin Reduced Risk of Disease Worsening or Death in Late-Stage Kidney Cancer Trial
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMmotion151 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin®(bevacizumab) provided a statistically significant and clinically meaningful reduction …