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FDA Approves Pembrolizumab for PD-L1+ Gastric Cancer

Jason M. Broderick @jasoncology
Published: Friday, Sep 22, 2017

The FDA has approved pembrolizumab (Keytruda) for the treatment of patients with PD-L1–positive recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received 2 or more lines of chemotherapy, including fluoropyrimidine- and platinum-containing chemotherapy, and, if appropriate, HER2/neu-targeted therapy.

Pembrolizumab is approved for several indications, including as a treatment for patients with lung cancer, melanoma, Hodgkin lymphoma, and other types of cancer. In mid-May, the FDA granted an accelerated approval to pembrolizumab as a treatment for patients without other options with unresectable or metastatic, MSI-H or mismatch repair deficient (dMMR) solid tumors. This was in addition to those with MSI-H or dMMR colorectal cancer following progression on a fluoropyrimidine, oxaliplatin, and irinotecan.

References

  1. FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1 (CPS Greater Than or Equal to 1). Merck. http://bit.ly/2wberGs. Accessed September 22, 2017.
  2. Fuchs CS, Doi T, Jang RW-J, et al. KEYNOTE-059 cohort 1: Efficacy and safety of pembrolizumab (pembro) monotherapy in patients with previously treated advanced gastric cancer. J Clin Oncol. 2017;35 (suppl; abstr 4003).

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