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FDA approves BMS’ Opdivo with chemotherapy for certain lung cancer patients

This is the first and only immunotherapy-based treatment approved for use before surgery for patients with non-small cell lung cancer


Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has approved Opdivo (nivolumab) for use in combination with chemotherapy every three weeks for three cycles.

The approval of the intravenous treatment is only for some adult patients with resectable non-small cell lung cancer (NSCLC).

The FDA’s approval is based on the CheckMate-816 trial – a randomised, open label trial – and is the first positive phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC.

The trial compared Opdivo plus chemotherapy to chemotherapy alone and the FDA has approved the use of Opdivo plus chemotherapy regardless of PD-L1 status.

When given before surgery, Opdivo plus chemotherapy demonstrated a statistically significant improvement in EFS, with a 37% decrease in the risk of progression, recurrence or death when compared to chemotherapy alone.

In the US, lung cancer is the leading cause of cancer deaths. The two main types of lung cancer are small cell and non-small cell, the latter of which accounts for up to 84% of diagnoses. The standard of care for resectable NSCLC is surgery, but the cancer recurs in 30% to 55% of patients who have surgery.

“Given the rates of disease recurrence in patients with resectable NSCLC, additional treatment options are needed that can be given before surgery to help improve the chance of successful surgical treatment and support the goal of reducing the risk of cancer returning,” said Mark Awad, CheckMate -816 study investigator and clinical director of the Lowe Center for Thoracic Oncology at Dana-Farber Cancer Institute.

“The approval of nivolumab with platinum-doublet chemotherapy marks a turning point in how we treat resectable NSCLC and it enables us to use immunotherapy and chemotherapy as neoadjuvant treatment for patients before surgery.”

The FDA approved the application under its Real-Time Oncology Review (RTOR) pilot programme, which focuses on ensuring the availability of safe and effective treatments for patients as early as possible.

The EFS data from the phase 3 CheckMate-816 trial is scheduled to be presented at the American Association for Cancer Research Annual Meeting 2022 in April.

Article by
Fleur Jeffries

7th March 2022

From: Regulatory



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