Priority review is intended to expedite the FDA's review of new drugs and vaccines that have the potential to offer significant improvements over available therapies for serious conditions.
On 15 Apr 2023, the updated PFS & OS from the interim analysis (data cutoff Oct 14, 2021) of the study (NCT03910127) was reported at the AACR Congress, illustrating its potential clinical benefits and setting the stage for further exploration.
Investigator-initiated trials (IITs) are established and managed by non-pharmaceutical researchers, such as clinicians and researchers working in a health institution.
The 2023 AACR Congress set the scene with the revelation of the latest clinical outcomes of HS-10365, a highly potent and selective RET TKI, offering significant insights into its potential therapeutic benefits.
In the Phase III trial for the initial treatment of recurrent/metastatic cervical cancer in all types of patients, Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) has achieved the primary goal of halting disease progression.
Gracell Biotechnologies reveals FDA approval for a Phase 1/2 Clinical Trial IND application concerning FasTCAR-T GC012F, aimed at treating stubborn Systemic Lupus Erythematosus.