February 2023 Brief

A first-in-human, multicenter, phase 1 clinical trial will begin to assess the safety, and biomarkers for response of DK210 in patients with advanced solid cancer who are overexpressing EGFR.

After more than 15 years with no new treatments for glioblastoma, a novel LSD1 small molecule has been granted orphan drug designation by the FDA.

The first-in-class PPT-1 inhibitor ezurpimtrostat has been granted an orphan drug designation by the FDA for patients with hepatocellular carcinoma.

As requested by the FDA, a new biologics license application including updated scientific rationale has been submitted for remestemcel-L as treatment for patients with steroid-refractory acute graft-vs-host disease.

Positive findings from the phase 3 TROPiCS-02 study have led to the FDA approval of sacituzumab govitecan-hziy for another indication.

Based on findings from the ROSALIA study, the FDA has accepted for review a proposed denosumab biosimilar for patients with osteoporosis and treatment-related bone loss in patients with cancer.

A regular approval has been granted to dostarlimab for the treatment of mismatch repair deficient recurrent or advanced endometrial cancer.

In an 8 to 5 vote, the FDA's Oncologic Drugs Advisory Committee supported the proposed clinical trial for dostarlimab as treatment of locally advanced, treatment-naïve mismatch-repair deficient or microsatellite-instability-high rectal cancer.

CINtec PLUS Cytology is the only dual-stain triage test to be offered by BioReference Health LLC for patients with a high-risk human papillomavirus result.

The partial clinical hold was put on the phase 1/2 VELA study after visual adverse events were observed in some patients with solid tumors after treatment with BLU-222.

The upcoming THIO-102 trial will evaluate the safety and efficacy of THIO administered in sequence with pembrolizumab or atezolizumab across multiple tumor types.

Further guidance from the FDA will be requested for the new drug application submission for SGX301 for the treatment of early-stage cutaneous T-cell lymphoma.

Results from cohort A of the MagnetisMM–3 trial of erlanatamab for patients with relapsed/refractory multiple myeloma have led the FDA to grant priority review to a biologics license application for the agent in this patient population.

The FDA has granted a breakthrough therapy designation to mRNA-4157/V940 based on data from KEYNOTE-942 which showed that the addition of an mRNA vaccine to adjuvant pembrolizumab improved recurrence-free survival following resection of high-risk melanoma.

A phase 1 dose-escalation and -expansion clinical trial will evaluate BA3182, a potential anticancer therapy, for patients with advanced adenocarcinoma based on the clearance of an investigational new drug application from the FDA.

Data from the phase 3 DeFi trial showed that nirogacestat led to a 71% reduction in the risk of disease progression compared with placebo for adult patients with desmoid tumors. Now, the FDA has granted a priority review to the new drug application for nirogacestat.

Based on the FDA’s review of a new drug application, a phase 2 study will evaluate the safety and efficacy of azeliragon for patients with glioblastoma.

Efficacy findings from CheckMate-76 have led the FDA to accept the supplemental biologics license application and the EMA to validate the type II variation marketing authorization application for nivolumab alone in stage IIB or IIC melanoma.