FDA and the the European Medicines Agency accepted the Supplemental Biologics License Application and Type II Variation, respectively, for Kymriah (tisagenlecleucel) in adult patients with relapsed or refractory (r/r) follicular lymphoma after two prior lines of treatment. FDA also granted priority review to the sBLA for Kymriah in adult patients with r/r FL.
The FDA Oncologic Drugs Advisory Committee on Sept. 26 voted that PD-L1 inhibitors should not be indicated as a first-line treatment for patients with PD-L1-negative gastric/gastroesophageal junction adenocarcinoma and esophageal squamous cell carcinoma.
