FDA Accepts Bristol Myers’s BLA for Non-Small Cell Lung Cancer Drug

FDA recently accepted Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for its non-small cell lung cancer (NSCLC) drug, Opdivo, plus chemotherapy.

The agency based its filing on results from the pivotal CheckMate-816 study. The trial enrolled 358 patients to randomly receive Opdivo 360 milligrams plus chemotherapy every three weeks or platinum doublet chemotherapy for three weeks, followed by surgery.

In the trial, Opdivo plus chemotherapy was statistically significant and clinically meaningful in complete response and event-free survival versus chemotherapy alone when given before surgery.

Notably, the safety profile of the combination treatment was also consistent with previously reported NSCLC studies.

“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,” Abderrahim Oukessou, MD, vice president, thoracic cancers development lead at Bristol Myers Squibb, said in the announcement.

“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,” Oukessou continued.

Lung cancer is the leading cause of cancer deaths globally among men and women (25 percent). The two main types of lung cancer are non-small cell and small cell. NSCLC is one of the most common types of lung cancer, representing up to 84 percent of diagnoses.

While surgery has cured many patients with NSCLC, between 30 to 55 percent experience recurrence after surgery and ultimately die from the disease.

In November 2021, Opdivo plus chemotherapy significantly improved event-free survival in patients with resectable stage IB to IIIA NSCLC.

This combination treatment previously showed notable improvement in pathologic complete response (pCR), the other primary endpoint of the trial. The safety profile was also consistent with prior NSCLC studies.

To date, Opdivo-based therapies have shown improved efficacy in the neoadjuvant or adjuvant treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma.