FDA Accepts sBLA, Grants Priority Review for Nivolumab in Previously Treated Patients With SCLC
On April 18, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is August 16, 2018.
Sabine Maier, MD, Development Lead, Thoracic Cancers, Bristol-Myers Squibb, commented, “Small cell lung cancer is a highly aggressive disease, one where most patients experience relapse within a year of diagnosis. The overall prognosis for this cancer remains poor, and there have been no new treatment advances in nearly 20 years. We are pleased with this important step forward in the FDA’s consideration to expand the use of nivolumab to patients with small cell lung cancer who have received two or more lines of previous treatment.”
The submission was based on safety and efficacy data from the SCLC cohort of the phase I/II CheckMate 032 trial evaluating nivolumab monotherapy following platinum-based chemotherapy.
About CheckMate 032
CheckMate 032 is a phase I/II open-label trial evaluating the safety and efficacy of nivolumab monotherapy or nivolumab plus ipilimumab (Yervoy) in advanced or metastatic solid tumors, including small cell lung cancer. Patients were treated until disease progression or unacceptable toxicity.
The trial included both programmed death-ligand 1 (PD-L1) expressors and nonexpressors. The primary endpoint was objective response rate as assessed by a blinded independent central review. Secondary endpoints included safety, overall survival, progression-free survival, and duration of response.
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