Pembrolizumab Approval Withdrawn for Third-Line Gastric Cancer Treatment

Yesterday, Merck announced that it will voluntarily withdraw the accelerated approval indication of pembrolizumab (Keytruda®, Merck) for patients with recurrent locally advanced/metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed death-ligand 1 (PD-L1) with a combined positive score (CPS) ≥1 and who experienced disease progression on or after two or more prior lines of therapy, including fluoropyrimidine- and platinum-containing chemotherapy and human e...
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Pembrolizumab Approved for HER2-Positive Gastric Cancer

The FDA has granted accelerated approval to pembrolizumab (Keytruda®, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2- positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. "The PD-1 (programmed cell death protein 1)/PD-L1 (programmed death-ligand 1) pathway is an important regulatory component of the immune response and plays a critica...
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FDA Approves Nivolumab With Chemotherapy for Gastric and Esophageal Cancer

The FDA has granted approval to nivolumab (Opdivo®, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the initial treatment of patients with advanced/metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. "Standard first-line chemotherapy options for advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric cancer/gastroesophageal junction cancer result in poor overall su...
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Metastatic Gastric Cancer: Educational Needs

Due to the advances in treatment options for metastatic gastric cancer in recent years, oncology physicians and nurses can individualize treatment selection for patients by considering pathologic and molecular characteristics and emerging efficacy and safety data on novel therapies. Baseline data collected from i3 Health's continuing medical education (CME)/nursing continuing professional development (NCPD)–approved visiting faculty meeting series titled Challenges and Opportunities in Metastati...
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Kohei Shitara, MD: Fam-Trastuzumab Deruxtecan-Nxki for Gastric Cancer

Fam-trastuzumab deruxtecan-nxki (Enhertu®, Daiichi Sankyo) has recently been FDA approved for the treatment of adult patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal adenocarcinoma previously treated with a trastuzumab-based regimen. In this interview with i3 Health, Kohei Shitara, MD, Chief of the Department of Gastrointestinal Oncology at the National Cancer Center Hospital East in Kashiwa, Japan, and lead investigator of the phase 3 DESTINY-Gastric01 trial, on which the approval was based, shares his insights on this approval, on the challenges of treating this patient population, and on the future of treatment for patients with gastric or gastroesophageal adenocarcinoma.

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