August 2023 Brief

IVS-3001, a chimeric antigen receptor therapy developed to target and kill HLA-G-bearing cells, is currently in late-stage preclinical development for the treatment of solid tumors.

A promising disease control rate and overall response rate was seen with elraglusib when given with chemotherapy for patients with pancreatic cancer, according to phase 2 study findings.

Trifluridine/tipiracil plus bevacizumab improved rates of progression-free and overall survival vs trifluridine/tipiracil alone in the SUNLIGHT study. Now, the combination is FDA-approved for patients with metastatic colorectal cancer.

ABM-1310 is a novel small molecule BRAF inhibitor that has shown promising anti-cancer activity and a good safety profile across a variety of advanced BRAF V600-mutant solid tumors.

Despite a favorable vote by the Oncologic Drugs Advisory Committee, the FDA has opted not to approve remestemcel-L for the treatment of pediatric steroid-refractory acute graft-vs-host disease.

Lisaftoclax is a novel, orally administered small-molecule BCL-2 selective inhibitor. A study of the agent in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma will commence in the second half of 2023.

Early clinical trial in gastrointestinal and brain cancers aim to better understand the safety and efficacy of CEND-1-targeted therapy and develop a novel CEND-1 agent.

Approval of pralsetinib for the treatment of RET fusion-positive non–small cell lung cancer in based on positive results from the phase 1/2 ARROW trial.

Data from the phase 2 MonumenTAL-1 study support the accelerated approval of talquetamab in patients with relapsed/refractory who have received at least 4 prior lines of therapy.

A phase 1/2 study marks the beginning of Genprex, Inc's clinical development of quratusugene ozeplasmid in small cell lung cancer.

Results from the phase 3 MAGNITUDE study have led to a quick FDA decision on the future of a dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer.

Findings from 2 cohorts of the phase 3 MagnetisMM-3 trial led to the FDA approval of elranatamab-bcmm for relapsed or refractory multiple myeloma treatment.

The first liver-directed therapy for the treatment of adult with metastatic uveal melanoma is now FDA approved.

An investigational HLA-LOH assay, xT CDx, now has the FDA's attention.

The FDA plans to conduct a speedy review of the supplemental new drug application for ivosidenib tablets as treatment of IDH1-positive, relapsed or refractory myelodysplastic syndrome.

A pause on trials of magrolimab in acute myeloid leukemia will affect the screening and enrollment of patients.

On the heels of promising findings from the phase 3 IMerge study, the FDA has accepted the new drug application of imetelstat for transfusion-dependent anemia in patients with lower-risk MDS.

The metastasis-free survival benefit of enzalutamide, and other efficacy and safety data are now under FDA review for the potential approval of the drug for patients with non-metastatic castration-sensitive prostate cancer.

FDA notices NXC-201 for its potential offer a novel mechanism to treat patients with multiple myeloma.

Novel agents are now under development for newly druggable targets in patients with solid tumors.

Based on positive phase 3 PAPILLON results, an application for a new approval for amivantamab has been filed with the FDA.

The FDA has added to the existing approval of luspatercept-aamt for the treatment of patients with anemia and lower-risk myelodysplatic syndrome.

Promising overall survival findings from cohort 1 of the THOR study evaluating erdafitinib in locally advanced or metastatic urothelial cancer have pushed the agent’s developer to submit an sNDA seeking its full approval.

The phase 1/2 BEXMAB study is investigating the combination of bexmarilimab with standard of care in patients with hematologic malignancies.

Fam-trastuzumab deruxtecan-nxki was granted 2 breakthrough therapy designations by the FDA for its potential to fill a treatment gap for HER2-expressing tumors.