Sammons Cancer Center at Baylor University Medical Center in Dallas, Texas.ĬheckMate 577 enrolled 794 patients with completely resected esophageal or GEJ cancer who had been previously treated with concurrent chemoradiotherapy and who had residual pathologic disease. Kelly, MD, Director of Oncology for the Charles A. "No adjuvant treatment has been established for patients who remain at high risk for recurrence after neoadjuvant chemoradiotherapy and surgery for esophageal or gastroesophageal junction cancer," wrote the investigators of the phase 3 CheckMate 577 trial (NCT02743494), on which the approval was based, led by first author Ronan J. Accessed May 20, 2021.The FDA has granted approval to nivolumab (Opdivo ®, Bristol Myers Squibb) for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer who have residual pathologic disease after prior neoadjuvant chemoradiotherapy. US 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. “Today’s news pioneering immunotherapy treatment options in earlier stages of disease where there is the potential to reduce the risk of recurrence.” “Esophageal and cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection face a high risk of disease recurrence however, the predominant option for these patients has been surveillance,” said Adam Lenkowsky, senior vice president and general manager of US Cardiovascular, Immunology, and Oncology at Bristol Myers Squibb, in the press release. This program aims to ensure that safe, effective treatments are available as early as possible. The application was reviewed as part of the FDA’s Real-Time Oncology Review pilot program, according to the press release. Nivolumab has several warnings and precautions, including severe and fatal immune-mediated adverse reactions infusion-related reactions complications of allogeneic hematopoietic stem cell transplantation embryo-fetal toxicity and increased mortality in patients with multiple myeloma when nivolumab is added to a thalidomide analogue and dexamethasone. “This is exciting news, providing renewed hope.” “In the CheckMate-577 trial, we saw a doubling in median disease-free survival compared to placebo, which suggests that Opdivo could become a new standard of care for these patients,” Kelly said in the press release. Among patients with squamous cell carcinoma, mDFS was 29.7 months in the nivolumab group and 11 months in the placebo group. Nivolumab also reduced the risk of disease recurrence or death by 31% compared to the placebo, according to a press release.Īn exploratory analysis also analyzed results among patients with adenocarcinoma and found that mDFA was 19.4 months among those treated with nivolumab compared to 11.1 months in patients treated with a placebo. The approval is based on the results from the phase 3 CheckMate-577 trial, which found that median disease-free survival (mDFS) was twice as long in patients who received nivolumab compared to patients who received a placebo, with mDFS of 22.4 months and 11 months, respectively. “Even after neoadjuvant CRT followed by surgery, there may be a high risk of recurrence for patients who do not achieve a pathologic complete response.” Sammons Cancer Center, in a press release. Kelly, MD, MBA, director of the Baylor Scott & White Charles A. “Locally advanced esophageal and gastroesophageal junction cancers are aggressive tumor types that often require multiple approaches to address the disease, including chemotherapy, radiation, and surgery,” said Ronan J. Officials with the FDA have approved nivolumab (Opdivo) as the first and only immunotherapy indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).
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