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Innovent Announces NMPA Acceptance of a Supplemental New Drug Application for Sintilimab in Combination with Chemotherapy as First-Line Treatment for Advanced or Metastatic Gastric or Gastroesophageal
prnasia
November 05, 2021
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer...
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HUTCHMED and AstraZeneca Begin Phase II Trial of ORPATHYS® in Gastric Cancer
americanpharmaceuticalreview
July 29, 2021
HUTCHMED and AstraZeneca PLC have initiated a Phase II study of ORPATHYS® (savolitinib), an oral, potent, and highly selective small-molecule inhibitor of MET, a receptor tyrosine kinase, in patients with advanced or metastatic MET amplified gastric ...
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Merck Provides Update on KEYTRUDA® Indication in Third-Line Gastric Cancer
americanpharmaceuticalreview
July 05, 2021
Merck announced plans to withdraw the U.S. accelerated approval indication for KEYTRUDA (pembrolizumab) for treatment of patients with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma, with disease progression on or after two or ...
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FDA Grants Bold Therapeutics' BOLD-100 an Orphan Drug Designation (ODD) in the Treatment of Gastric Cancer
americanpharmaceuticalreview
May 12, 2021
Bold Therapeutics, a clinical-stage biopharmaceutical company, announced that the U.S. Food & Drug Administration (FDA) has granted BOLD-100 an Orphan Drug Designation (ODD) in the treatment of gastric (stomach) cancer.
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Breakthrough designation granted for Amgen’s bemarituzumab
pharmatimes
April 21, 2021
Amgen’s investigational medicine bemarituzumab has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA).
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Ambrx gets orphan drug designation for gastric cancer treatment ARX788
pharmaceutical-business-review
March 23, 2021
The US Food and Drug Administration (FDA) grants orphan drug designation to Ambrx for ARX788, a homogeneous and highly stable antibody drug conjugate, for the treatment of HER2-positive gastric cancer.
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AZ, Daiichi Sankyo’s Enhertu wins US approval for HER2-positive gastric cancer
pharmatimes
January 19, 2021
AstraZeneca and Daiichi Sankyo’s HER2-targeting antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received approval in the US for the treatment of locally advanced/metastatic HER2-positive gastric or gastroesophageal junction (GEJ) ...
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Zymeworks gets EC’s orphan drug designation for zanidatamab in patients with gastric cancer
pharmaceutical-business-review
November 24, 2020
Zymeworks announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in patients with gastric cancer.
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Enhertu bags US priority review for HER2 gastric cancer
pharmatimes
October 29, 2020
AstraZeneca’s Enhertu has scored a priority review from the US Food and Drug Administration (FDA) for the treatment of HER2-positive metastatic gastric cancer.
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BMS’ Opdivo improves survival in gastric and oesophageal cancers
pharmatimes
August 13, 2020
Bristol Myers Squibb has revealed the results from the Phase III CheckMate-649 evaluating Opdivo (nivolumab) plus chemotherapy in first-line metastatic gastric cancer, gastroesophageal junction (GEJ) cancer or oesophageal adenocarcinoma.