The FDA recently granted priority review designation to Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), according to a Bristol Myers Squibb press release.
The nivolumab and ipilimumab will be administered in combination with limited chemotherapy for patients with MSCLC with no EGFR or ALK genomic tumor aberrations. The FDA set a PDUFA date of August 6, 2020 for the priority review, while also granting fast track designation to the combination.
“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” Sabine Maier, MD, development lead, thoracic cancers, Bristol Myers Squibb, said in a press release. “The FDA’s…
