FDA submission
Lifileucel's BLA is again delayed, but a 33-month update from a pivotal melanoma trial, along with early data from a frontline study, show continued potential.
Engineered TCR Therapy Demonstrates Durable Responses in Rare Sarcomas
Adaptimmune is advancing regulatory plans for its autologous TCR treatment, afami-cel, for advanced sarcoma based on Phase II trial results.
Novartis On Track to Pursue Kymriah Approval in Follicular Lymphoma After Promising Results
The firm announced positive data from the Phase II ELARA trial and said it will seek regulatory approval for the CAR T-cell therapy in refractory follicular lymphoma.
Kiromic Biopharma Submits IND to FDA for CAR T-Cell Therapy Targeting Iso-Mesothelin
The company expects to begin a Phase I trial of its iso-mesothelin-targeted therapy in solid tumors in Q3 of 2021.
FDA Accepts Takeda's NDA for EGFR Exon20 Insertion-Mutated NSCLC Treatment
The agency granted priority review to Takeda's mobocertinib application seeking approval in metastatic non-small cell lung cancer patients with certain EGFR mutations.