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.
May 2023 Brief
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.
Two genetically engineered gamma-delta T-cell therapies, INB-400 and INB-410, have been granted an orphan drug designation from the FDA for numerous types of malignant glioma.
FDA approval has not been granted to N-803 for the treatment of Bacillus Calmette–Guérin-unresponsive non-muscle-invasive bladder cancer carcinoma in situ.
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.
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.
The fast track designation to IMPT-314 is for the treatment of multiple types of B-cell lymphoma in patients who previously received 2 or more lines of systemic therapy.
Phase 3 results from the combination of rivoceranib and camrelizumab have excited investigators enough to seek FDA approval for patients with unresectable hepatocellular carcinoma.
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.
The FDA has approved avapritinib for adult patients with indolent systemic mastocytosis based on findings from the phase 2 PIONEER trial.
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.
The claudin 18.2 antibody-drug conjugate ATG-022 is being investigated in a phase 1 study as a potential treatment for advanced or metastatic solid tumors.
If granted approval, fruquintinib will be the first and only highly selective inhibitor of all 3 VEGF receptors to be approved in the United States for patients with metastatic colorectal cancer.
Results from TRIDENT-1 are supporting a new drug application for repotrectinib, a potential treatment for ROS1-positive advanced non–small cell lung cancer.
The FDA has approved the flotufolastat F 18 injection for positron emission tomography of prostate-specific membrane antigen–positive lesions in patients with prostate cancer.
The biologics license application for lifileucel has been accepted by the FDA for patients with advanced melanoma based on positive data from the C-144-01 clinical trial.
Findings from the phase 3 PROpel have led to the FDA approval of olaparib in combination with abiraterone and prednisone or prednisolone for a prostate cancer subgroup.