June 20 Quick Takes: EMA reviewing BMS’s Breyanzi

Breyanzi lisocabtagene maraleucel, a CD-19 CAR T cell therapy from Bristol Myers Squibb Co. (NYSE:BMY), is now under review by EMA for diffuse large B cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B cell lymphoma and follicular lymphoma grade 3B in adult patients who are refractory or have relapsed within 12 months of first-line therapy. FDA is reviewing a sBLA for the product for large B cell lymphoma, with a PDUFA date of June 24. An NDA is under review at Japan’s Ministry of Health, Labour and Welfare (MHLW) for the same indication.

NMPA approved an sNDA from Innovent Biologics Inc. (HKEX:1801) for Tyvyt sintilimab to treat esophageal squamous cell in the first-line setting, in combination with chemotherapy. Tyvyt is already approved by NMPA to treat non-squamous NSCLC and refractory classical Hodgkin lymphoma, and is under review by the agency to treat gastric or gastroesophageal junction adenocarcinoma and EGFR-mutated non-squamous NSCLC. However, the therapy has faced regulatory setbacks in the U.S. due to a reliance on China-only data and is not approved by FDA for any indication. ...