Specialty Pharma Journal Specialty, Precision & Technology
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) …
Tag Archives: Avastin
June, 2018
January, 2018
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3 January
Myriad and AstraZeneca Partner on Phase 3 PARP Inhibitor Trial Utilizing myChoice HRD Plus as a Companion Diagnostic
SALT LAKE CITY, Jan. 03, 2018 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that AstraZeneca will use the Company’s myChoice® HRD Plus in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza …
December, 2017
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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 …
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7 December
Genentech’s Tecentriq Combo Succeeds in Pivotal Trial of Untreated Lung Cancer Patients
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from the positive, pivotal Phase III IMpower150 study of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus chemotherapy (carboplatin and paclitaxel) in people with previously untreated, advanced non-squamous non-small cell lung cancer (NSCLC). The study …
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7 December
FDA Grants Full Approval for Genentech’s Avastin for the Treatment of Glioblastoma
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has granted full approval for Avastin®(bevacizumab) for the treatment of adults with glioblastoma that progressed following prior therapy (referred to as recurrent disease). Avastin …
November, 2017
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20 November
Genentech’s Cancer Combo Demonstrates Positive Late-Stage Results in Patients with Advanced NSCLC
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant …
October, 2017
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27 October
FDA Accepts Genentech’s sBLA for Avastin as a Front-Line Treatment of Advanced Ovarian Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the …
July, 2017
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24 July
Pfizer Announces Positive Top-Line Results from Comparative Study for PF-06439535, a Potential Biosimilar to Avastin
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin® (bevacizumab), met its primary objective. PF-06439535 is being developed by Pfizer as a potential biosimilar to Avastin. The trial demonstrated equivalence in the primary endpoint of objective …
June, 2017
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7 June
FDA Advisory Committee to Review Amgen and Allergan’s Biosimilar Candidate to Bevacizumab
THOUSAND OAKS, Calif., June 7, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Biologics License Application (BLA) for ABP 215, a biosimilar candidate to Avastin® (bevacizumab), …
December, 2016
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6 December
FDA Expands Approval of Genentech’s Avastin for a Specific Type of Advanced Ovarian Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Avastin®(bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the …