FDA Reviewing Iovance's BLA for Melanoma TIL Therapy; Decision Expected in November
Iovance said the FDA is reviewing its BLA, and if successful, lifileucel could be the first autologous cell therapy approved for solid cancer.
Based on their success treating C. difficile, drugmakers are using different strategies to develop microbiome cancer therapies, including using genomics tools to home in on patient-specific strategies.
FDA Accepts BMS's NDA for Repotrectinib in ROS1-Positive NSCLC
The agency is reviewing data from the Phase II TRIDENT trial and expects to decide whether to approve the drug by Nov. 27.
Bioinformatics Tool for Tracking Tumor-Immune Interactions Could Be Useful for Guiding Therapy
A map for discovering immune checkpoints and tumor process interactions is showing potential in identifying new drug targets and personalizing immunotherapy.
EMA's CHMP Recommends BMS's Opdivo, Chemo for Neoadjuvant PD-L1-Positive NSCLC
If approved, the drug combination will be the first immunotherapy-based treatment available in the neoadjuvant setting for NSCLC patients in Europe.