In CheckMate -577, Opdivo
1
Approval expands the role of Opdivo in earlier stages of disease, with two indications in the adjuvant setting across three types of cancer
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PRINCETON, NJ, USA I May 20, 2021 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved
Opdivo
® (nivolumab, injection for intravenous use) for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
1 The approval is based on results from the Phase 3 CheckMate -577 trial that evaluated
Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.
OSE Immunotherapeutics and Veloxis Pharmaceuticals Enter Into Global License Agreement to Develop, Manufacture, and Commercialize FR104, a CD28 Antagonist, in the Organ Transplantation Market
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SAN FRANCISCO, CA, USA and SUZHOU, China I February 08, 2021 I Innovent Biologics, Inc. ( Innovent ) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the first patient has been successfully enrolled and dosed in the randomized, open-label, phase III, multicenter clinical study (NCT04720716) evaluating its IBI310 (anti CTLA-4 monoclonal antibody) in combination with TYVYT® (sintilimab injection) for the first-line treatment of patient with advanced hepatocellular carcinoma (HCC).
In recent years, immune checkpoint inhibitors have brought new hope to HCC patient population with acceptable safety and encouraging efficacy. NCT04720716 is a randomized, open-label, controlled, multicenter phase III study evaluating the efficacy and safety of IBI310 in combination with TYVYT® (sintilimab injection) for
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First HER2 directed medicine approved for patients with gastric cancer in a decade
TOKYO, Japan & MUNICH, Germany & BASKING RIDGE, NJ USA I January 15, 2021 I Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s
ENHERTU
® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
In the U.S., gastric cancer is more frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving five years.
1,2 Approximately one in five gastric cancers are HER2 positive.