Postoperative ancillary treatment of esophageal cancer/gastroesophageal cancer! Pepsi Opdivo receives FDA Priority Review: Significantly Extending Disease-Free Survival!

Jan. 20, 2021 // -- BMS recently announced that the U.S. Food and Drug Administration (FDA) has accepted the anti-PD-1 therapy Opdivo (Odi) Waugh, generic name: nivolumab, Navuliyu mono-anti) A supplementary biological product licensing application (sBLA), which seeks approval for Opdivo for complementary treatment of adult patients with esophageal or gastroesophageal connection (GEJ) cancer who have undergone new assisted chemotherapy (CRT) and excision.
FDA has granted the sBLA priority review and has designated a target date of the Prescription Drug User Charge Act (PDUFA) as May 20, 2021.
month, Opdivo's application for the allergy was also accepted by the European Medicines Agency (EMA) and a centralized review process has been initiated.
application is based on the results of Phase 3 CheckMate-577 trials.
data show that opdivo-assisted therapy doubled the patient's disease-free survival (DFS) (median DFS: 22.4 months vs. 11.0 months) compared to placebo in patients with new assisted CRT and surgical removal.
, the standard treatment for patients with esophageal and GEJ cancers who have underwent new assisted simultaneous chemotherapy and surgical removal is surveillance follow-up.
results confirm for the first time that complementary therapy can significantly extend the disease-free survival of such patients. "The FDA has accepted our application, marking significant progress in advancing our goal of advancing treatment options for patients with esophageal cancer or gastroesophageal connectivity (GEJ) cancer," said Dr. Ian M. Waxman, M.D., head of gastrointestinal tumor development at
Centennia.
these patients face significant unseeded needs, as there is still a high risk of disease recurrence.
look forward to working with the FDA to provide Opdivo treatment to patients.
" esophageal cancer (Photo: medindia.net) CheckMate-577 is a randomized, double-blind, multi-center Phase 3 study designed to assess the efficacy and safety of Opdivo as an auxiliary treatment for patients with removable esophageal cancer and GEJ cancer who are not fully pathologically remission after the new auxiliary CRT.
end of the study was disease-free lifetime (DFS) and the secondary endpoint was total survival (OS).
after receiving new assisted synchrectomy and complete tumor excision (also known as triple therapy), 794 patients were randomly assigned to the placebo group (N-262) or the Opdivo group (N-532).
Opdivo patients received Opdivo 240 mg, every 2 weeks intravenous drips, after 16 weeks of continuous medication, sequentatly Opdivo 480 mg, every 4 weeks intravenous drips, until the disease relapsed, insatiable toxicity or the patient withdrew informed consent, the total duration of treatment is up to one year.
the results, published in September 2020, showed that the Opdivo group showed statistically significant and clinically significant improvements in disease-free survival (DFS) at the main study endpoint compared to the placebo group.
compared to the placebo group (11.0 months; 95% CI: 8.3-14.3), the mid-level DFS in the patient group treated with Opdivo doubled after surgery (22.4 months vs 11.0 months; HR=0.69; p=0.0003).
10 months (10.1 months) in patients in the Opdivo group.
, the safety of Opdivo monodrug therapy was consistent with previous studies.
is safe and well-to-do compared to placebos.
in the Opdivo group, the majority of patients (89%) were able to ≥ 90% of the relative dose intensity.
patients treated with Opdivo, the rates of adverse events (TRAEs) associated with treatment at all levels were 71% and 13%, respectively, and in the placebo group 46% and 6%, respectively.
in the Opdivo group, less than 10 percent of patients had severe TRAE (all levels: 8 percent, 3-4: 5 percent), and the placebo group had 3 percent and 1 percent, respectively.
in both groups, drug suspension rates were lower due to any level of TRAEs (Opdivo group: 9%, placebo group: 3%).
esophageal cancer is the seventh most common cancer in the world and the sixth leading cause of death.
2018, there will be about 572,000 new cases of esophageal cancer and more than 508,000 deaths worldwide.
, esophageal cancer is the sixth most common cancer and the fourth leading cause of cancer death, after lung, stomach and liver cancers.
squamous cell carcinoma and adenocarcinoma remain the two most common types of esophageal cancer, accounting for nearly 85% and 15% of the total number of esophageal cancer patients, respectively.
most people with esophageal cancer are diagnosed with advanced stages and their daily lives, including their diet, are affected.
is the fifth most common cancer in the world and the third leading cause of death.
2018, there will be more than 1 million new cases of stomach cancer and about 783,000 deaths worldwide.
broader definition of stomach cancer, including gastroesophageal joint (GEJ) cancer, which forms at the junction of the stomach and esophageal, can be attributed to stomach cancer.
compared with stomach cancer, the prevalence of gastroesophageal cancer is low, but it is on the rise.
Opdivo belongs to PD-(L)1 tumor immunotherapy, designed to use the body's own immune system to fight cancer, by blocking the PD-1/PD-L1 signaling path path to death cancer cells, has the potential to treat a variety of types of tumors.
, Opdivo has been approved for a variety of cancer adaptations.
approved in June 2018 as the first approved immuno-tumor (I-O) treatment in the Chinese market.
In March 2020, the National Drug Administration (NMPA) approved Opdivo for the treatment of patients with advanced or relapsed stomach or gastroesophageal adenocarcinoma who had previously received two or more systemic treatment options.
The approval of the gastric/gastroesophageal junction adenocarcinoma adaptation is also the third adaptation approved in China, following non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (SCCHN).
() original source: U.S. Food and Drug Administration Accepts for Priority Review application for Opdivo® (nivolumab) as Adjuvant Therapy for Patients with Resected Esophageal or Gastroesophageal Junction Cancer