EP. 1: FDA Accepts sBLA of Luspatercept for Anemia in Patients With Lower-Risk MDSMay 1st 2023
Findings from the COMMANDS study in which luspatercept showed statistically significant and clinically meaningful improvements for patients with low-risk myelodysplastic syndrome, the FDA has set a target action date of August 28, 2023.
EP. 2: FDA Approves FoundationOne® Liquid CDx as Companion Diagnostic for Mobocertinib in EGFRm NSCLCMay 4th 2023
The FoundationOne® Liquid CDx has been granted approval by the FDA as a companion diagnostic for mobocertinib for patients with locally advanced or metastatic non–small cell lung cancer harboring an EGFR exon 20 insertion mutation.
EP. 5: FDA Grants FTD to ACR-368 for Platinum-Resistant Ovarian and Endometrial CancerMay 11th 2023
ACR-368 generated deep and durable responses across several phase 2 studies. The agent has now been granted fast track designations for patients with platinum-resistant ovarian cancer and endometrial cancer.
EP. 6: FDA Grants SGX301 a Type A Meeting for the Treatment of CTCLMay 15th 2023
The FLASH study and compatibility study of SGX301 led to promising safety and efficacy responses for the treatment of cutaneous T-cell lymphoma. Now, the FDA has granted a type A meeting to discuss the design of a second trial of SGX301.
EP. 9: FDA Grants Orphan Drug Designation to Rucosopasem for Pancreatic CancerMay 19th 2023
Rucosopasem manganese is being investigated in the phase 1/2 GRECO-1 and phase 2b GRECO-2 trials in combination with stereotactic body radiation therapy for the treatment of patients withlj non–small cell lung cancer and pancreatic cancer.
EP. 11: FDA Grants Orphan Drug Designation to Mitazalimab for Pancreatic CancerMay 23rd 2023
Mitazalimab has received an orphan drug designation from the FDA and is currently being investigated in the OPTIMIZE-1 trial in combination with modified FOLFIRINOX for the treatment of patients with pancreatic cancer.