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OncLive's April Roundup of Key FDA Decisions in Oncology

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Agnostic Approval of Trastuzumab Deruxtecan Ushers in New Option for Advanced HER2+ Solid Tumors

Ronan J. Kelly, MD, MBA, discusses the significance of the FDA approval of trastuzumab deruxtecan for pretreated, advanced HER2-positive solid tumors. ....

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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy | Antibodies

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
1
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. ....

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Investegate |AstraZeneca PLC Announcements | AstraZeneca PLC: Enhertu approved in the US for gastric cancer

previously treated HER2-positive advanced gastric cancer

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) s
Enhertu
(trastuzumab deruxtecan) has been approved
in the US 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 US, gastric cancer is most frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving beyond five years.
1,2 Approximately one in five gastric cancers are HER2 positive.
3

The approval by the Food and Drug Administration (FDA) was based on the positive results from the randomised DESTINY-Gastric01 Phase II trial conducted in Japan and South Korea. In the trial, Enhertudemonstrated a statistically significant and clinically meaningful improvement in ....

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ADDING MULTIMEDIA — ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Trea

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18-Jan-2021
ADDING MULTIMEDIA ENHERTU® Approved in the U.S. for the Treatment of Patients with Previously Treated HER2 Positive Advanced Gastric Cancer
First HER2 directed medicine approved for patients with gastric cancer in a decade
TOKYO & MUNICH & BASKING RIDGE, N.J. (BUSINESS WIRE) 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. ....

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