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: kidney cancer
October, 2018
August, 2018
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16 August
Natera and Fox Chase Cancer Center to Collaborate to Assess the Signatera Customized ctDNA Assay for Monitoring Kidney Cancer
SAN CARLOS, Calif., Aug. 15, 2018 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, has partnered with Fox Chase Cancer Center, one of the leading cancer centers in the United States, to assess the company’s Signatera™ (Research-Use Only) customized circulating tumor DNA (ctDNA) assay for …
April, 2018
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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 …
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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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 …
September, 2017
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20 September
FDA Advisory Committee Split on Opinion of Adjuvant Sutent for High-Risk Renal Cell Carcinoma
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) voted 6 in favor and 6 against the benefit-risk profile for SUTENT® (sunitinib) as adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy (surgical …
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7 September
Bristol-Myers Stops Late-Stage Kidney Cancer Trial Early Following Successful Results
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) announced today that a Phase 3 study evaluating Opdivo plus Yervoy in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) met its co-primary endpoint, demonstrating superior overall survival (OS) compared to sunitinib in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved …
August, 2017
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16 August
Bristol-Myers Squibb’s Kidney Cancer Drug Met Co-Primary Endpoint in Late-Stage Trial
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced topline results today from the CheckMate -214 trial investigating Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in intermediate and poor-risk patients previously untreated advanced or metastatic renal cell carcinoma. The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR …
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16 August
Exelixis Submits sNDA for Cabometyx for the Treatment of Previously Untreated Advanced Kidney Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX®(cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). The sNDA submission is based on …