Opdivo Gets FDA Priority Review for Presurgical NSCLC Treatment


The Food and Drug Administration plans to speed up its review of Opdivo in the pre-surgical setting for patients with non-small cell lung cancer.

The Food and Drug Administration (FDA) accepted a priority review for a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus chemotherapy for the neoadjuvant (pre-surgical) treatment of patients with resectable non-small cell lung cancer (NSCLC), according to Bristol Myers Squibb, the manufacturer of the immunotherapy agent.

Priority reviews are granted to drugs that show promise in treating an illness; and speed up the FDA’s review – and potential approval – of the therapy. Now, the FDA plans on deciding whether to approve Opdivo in this setting by July 13, 2022.

The priority review is based on findings from the phase 3 CheckMate-816 clinical trial, which showed that Opdivo plus chemotherapy led to a statistically significant and clinically meaningful improvement in pathologic complete response (where there is an absence of tumor cells in a sample taken from the patient), as well as event-free survival (the length of time where a patient is receiving a drug and does not have any complications) compared to chemotherapy alone.

Updated results from CheckMate-816 will be presented at an upcoming medical meeting, according to Bristol Myers Squibb.

“While significant progress has been made in how we treat non-small cell lung cancer, there remains a strong need for new options that can prevent recurrence and improve clinical outcomes, especially when a patient’s cancer is caught in earlier stages,” said Dr. Abderrahim Oukessou, vice president and thoracic cancers development lead at Bristol Myers Squibb, in a statement.

Opdivo was overall well-tolerated in CheckMate-816, and side effects were similar to what has previously been reported with the use of Opdivo. Since the drug works by activating the immune system to find and fight cancer, inflammation can happen anywhere throughout the body. Patients on Opdivo should know what immune-related side effects to look out for, and when to call their health care providers.

“The FDA’s acceptance of our application marks an important step in our effort to offer patients and physicians the first immunotherapy-based option that can be given before surgery to extend the time patients can continue living without disease progression or recurrence. We look forward to working with the FDA to potentially bring this regimen to patients in the U.S., where lung cancer is the leading cause of cancer deaths,” Oukessou said.

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