phase III clinical study
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.
Janssen Seeking European Approval for Carvykti as Earlier Refractory Multiple Myeloma Treatment
The firm submitted data from CARTITUDE-4, which showed the CAR T-cell therapy improved patients' progression-free survival compared to standard-of-care regimens.
Sangamo Therapeutics Prepping for Phase III Fabry Disease Gene Therapy Trial
Having garnered fast-track designation from the FDA and spurred by promising Phase I/II data, the firm is hoping to begin a late-stage trial of ST-920 by year-end.
AstraZeneca Sees New Lung Cancer Indication for Tagrisso, Chemo in FLAURA2 Data
Based on high-level results from the trial, the firm believes the combination could be a new first-line option for patients with advanced EGFR-mutated NSCLC.
FDA Sends Byondis Complete Response Letter Delaying Decision on HER2-Positive Breast Cancer Drug
Byondis submitted data on SYD985's activity from the Phase III TULIP trial, but the agency has requested additional information.