Bristol Myers Squibb has received the US Food and Drug Administration (FDA) approval for Opdivo (nivolumab) to treat a type of esophageal squamous cell carcinoma (ESCC).
The US regulatory agency has indicated Opdivo for the treatment of patients with unresectable advanced, recurrent or metastatic ESCC after prior fluoropyrimidine- and platinum-based chemotherapy. FDA has also granted priority review designation for the drug.
In addition, the FDA recommended dosage for Opdivo, which includes 240 mg IV infusion over 30 minutes every two weeks or 480 mg IV infusion over 30 minutes every four weeks.
Bristol Myers Squibb general manager and US oncology, immunology, cardiovascular head Adam Lenkowsky said: “Many cases of esophageal cancer are diagnosed at the advanced stage, when the disease could have a significant impact on a patient’s health.3 Treatment options can be limited once patients with advanced esophageal squamous cell carcinoma progress.
The approval of Opdivo as a new treatment option for previously treated patients with advanced esophageal squamous cell carcinoma, regardless of PD-L1 expression, highlights our commitment to providing new options to address the unmet needs of patients and brings us another step closer to understanding the full potential of immunotherapy for gastrointestinal cancers.”
The FDA approval for Opdivo is based on Phase 3 ATTRACTION-3 clinical trial
Bristol Myers Squibb said that the FDA approval is based on the Phase 3 ATTRACTION-3, a multicentre, randomised, active-controlled, open-label clinical trial that evaluated Opdivo compared to taxane chemotherapy.
The major efficacy outcome measure for the clinical study was overall survival (OS), and additional efficacy outcome measures include overall response rate (ORR) and progression-free survival (PFS) as assessed by the investigator using RECIST v1.1 and duration of response (DOR).
In the clinical study, Opdivo showed superior OS than taxane chemotherapy. The serious adverse reactions occurred in patients receiving Opdivo include pneumonia, esophageal fistula, interstitial lung disease and pyrexia.
The fatal adverse reactions include interstitial lung disease or pneumonitis, pneumonia, septic shock, esophageal fistula, gastrointestinal haemorrhage, pulmonary embolism, and sudden death. The most common adverse reactions were rashes and decreased appetite.
The company said that Opdivo marks the first approved immunotherapy for ESCC regardless of tumour PD-L1 expression level.
