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▎The content team editor of WuXi AppTec today, Bristol-Myers Squibb (BMS) announced that the US FDA has approved Opdivo (nivolumab) as an adjuvant therapy for the treatment of esophageal cancer or gastroesophageal junction ( GEJ) Cancer patients.
These patients found residual pathological disease after receiving neoadjuvant chemoradiation (CRT).
The press release states that Opdivo is the first immunotherapy approved for adjuvant treatment of this patient group.
Esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of cancer deaths.
Squamous cell carcinoma and adenocarcinoma are the two most common types, accounting for nearly 84% and 15% of the total number of esophageal cancer patients, respectively, but the histological characteristics of esophageal cancer vary from region to region.
In China, esophageal cancer is the sixth most common cancer and the fourth leading cause of cancer death, after lung cancer, stomach cancer and liver cancer.
Most patients with esophageal cancer are already at an advanced stage when they are diagnosed, and their daily life, including their diet, will be affected.
This approval is based on the results of a randomized, double-blind, placebo-controlled Phase 3 trial called CHECKMATE-577, which included 794 patients with esophageal cancer or GEJ cancer who underwent complete resection.
The results of the trial showed that compared with the placebo group, the disease-free survival (DFS) of patients treated with Opdivo showed a statistically significant improvement.
The median DFS in the Opdivo group was 22.
4 months (95% CI: 16.
6, 34.
0), and the value in the control group was 11 months (95% CI: 8.
3, 14.
3).
Regardless of tumor PD-L1 expression and histology, DFS benefit was observed.
The most common adverse reactions (incidence ≥20%) in patients receiving Opdivo are fatigue, rash, musculoskeletal pain, itching, diarrhea, nausea, weakness, cough, dyspnea, constipation, decreased appetite, back pain, joint pain, Upper respiratory tract infection, fever, headache, abdominal pain and vomiting.
"Patients with esophageal cancer and GEJ cancer with residual pathological diseases after receiving neoadjuvant chemotherapy and radiotherapy face a high risk of disease recurrence after undergoing complete resection.
However, the main choice for these patients is monitoring and observation.
" Bristol-Myers Squibb Mr.
Adam Lenkowsky, Senior Vice President of Cardiovascular, Immunology and Oncology of the United States, said, “Today’s approval is an important advancement for patients, and it also marks that our efforts to develop immunotherapeutic options in patients with early disease have achieved meaningful results.
progress."Reference: [1] 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.
Retrieved May 20, 2021, from https://www.
businesswire.
com/news/home/20210520005931/en[2] FDA approves nivolumab for resected esophageal or GEJ cancer.
Retrieved May 20, 2021, from/fda-approves-nivolumab-resected-esophageal-or-gej-cancer Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital.
These patients found residual pathological disease after receiving neoadjuvant chemoradiation (CRT).
The press release states that Opdivo is the first immunotherapy approved for adjuvant treatment of this patient group.
Esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of cancer deaths.
Squamous cell carcinoma and adenocarcinoma are the two most common types, accounting for nearly 84% and 15% of the total number of esophageal cancer patients, respectively, but the histological characteristics of esophageal cancer vary from region to region.
In China, esophageal cancer is the sixth most common cancer and the fourth leading cause of cancer death, after lung cancer, stomach cancer and liver cancer.
Most patients with esophageal cancer are already at an advanced stage when they are diagnosed, and their daily life, including their diet, will be affected.
This approval is based on the results of a randomized, double-blind, placebo-controlled Phase 3 trial called CHECKMATE-577, which included 794 patients with esophageal cancer or GEJ cancer who underwent complete resection.
The results of the trial showed that compared with the placebo group, the disease-free survival (DFS) of patients treated with Opdivo showed a statistically significant improvement.
The median DFS in the Opdivo group was 22.
4 months (95% CI: 16.
6, 34.
0), and the value in the control group was 11 months (95% CI: 8.
3, 14.
3).
Regardless of tumor PD-L1 expression and histology, DFS benefit was observed.
The most common adverse reactions (incidence ≥20%) in patients receiving Opdivo are fatigue, rash, musculoskeletal pain, itching, diarrhea, nausea, weakness, cough, dyspnea, constipation, decreased appetite, back pain, joint pain, Upper respiratory tract infection, fever, headache, abdominal pain and vomiting.
"Patients with esophageal cancer and GEJ cancer with residual pathological diseases after receiving neoadjuvant chemotherapy and radiotherapy face a high risk of disease recurrence after undergoing complete resection.
However, the main choice for these patients is monitoring and observation.
" Bristol-Myers Squibb Mr.
Adam Lenkowsky, Senior Vice President of Cardiovascular, Immunology and Oncology of the United States, said, “Today’s approval is an important advancement for patients, and it also marks that our efforts to develop immunotherapeutic options in patients with early disease have achieved meaningful results.
progress."Reference: [1] 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.
Retrieved May 20, 2021, from https://www.
businesswire.
com/news/home/20210520005931/en[2] FDA approves nivolumab for resected esophageal or GEJ cancer.
Retrieved May 20, 2021, from/fda-approves-nivolumab-resected-esophageal-or-gej-cancer Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.
If you need treatment plan guidance, please go to a regular hospital.
