Tag Archives: mUC

May, 2017

10 May
Genentech’s Tecentriq Misses Primary Endpoint in Late-Stage Bladder Cancer Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX:RO, ROG; OTCQX:RHHBY), today announced that the Phase III IMvigor211 study that evaluated TECENTRIQ® (atezolizumab) in people with locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after treatment with a platinum-based chemotherapy (previously treated) did …
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1 May
FDA Grants Accelerated Approval to AstraZeneca’s Imfinzi for Advanced Bladder Cancer

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZI™ (durvalumab). IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following …
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18 April
FDA Grants Accelerated Approval to Genentech’s Tecentriq for Treatment of Advanced Bladder Cancer

South San Francisco, CA — April 17, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval to TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who …
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3 February
FDA Accepts Two sBLA’s for Merck’s Keytruda

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a …
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3 February
FDA Approves Bristol-Myers Squibb’s Opdivo for Treatment of Bladder Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivo injection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 …
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15 March
FDA Grants Genentech’s Immunotherapy Priority Review for Advanced Bladder Cancer

South San Francisco, CA — March 14, 2016 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of …
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8 January
Roche Announces Encouraging Results from its Bladder Cancer Study

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced updated results from the pivotal phase II study, IMvigor 210, of the investigational cancer immunotherapy atezolizumab (MPDL3280A) in people with locally advanced or metastatic urothelial carcinoma (mUC). Median overall survival (mOS) in this heavily pre-treated population was 11.4 months [95% CI: 9.0, …
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