June 2023 Brief

The FDA is no longer concerned about the safety of MT-0169, and the developer of the agent plans to focus its effort on the extramedullary myeloma population.

Now that the FDA has lifted the partial clinical hold on the phase 1 study of FHD-286 in patients with relapsed/refractory acute myelogenous leukemia and myelodysplastic syndrome, there are plans to initiate a trial to further assess the agent with decitabine or cytarabine.

A regular review of an FDA approval application is underway for the combination of pembrolizumab and standard chemotherapy for the treatment of advanced biliary tract cancer.

The FoundationOne®Liquid CDx has received FDA approval as a companion diagnostic for encorafenib plus cetuximab for patients with BRAF V600E-mutated metastatic colorectal cancer.

Data from the phase 3 CAPItello-291 trial of capivasertib plus fulvestrant in HR-positive, HER2-negative locally advanced or metastatic breast cancer have led the FDA to grant priority review to the new drug application for the combination.

The FDA has requested additional time to assess the analyses of previously submitted data from the phase 3 DeFi trial of nirogacestat in desmoid tumors, leading to an extension of the Prescription Drug User Fee Act decision date.

A newly authorized phase 1b study will evaluate the safety and efficacy of the continuous delivery of lenalidomide among patients with multiple myeloma.

Data from the phase 3 NAPOLI 3 trial have led the FDA to accept a supplemental new drug application for NALIRIFOX in patients with metastatic pancreatic ductal adenocarcinoma

Glofitimab is the first and only CD20xCD3 T-cell engaging bispecific antibody approved for the treatment of relapsed/refractory DLBCL.

The FDA’s Oncologic Drugs Advisory Committee discussed the potential need for interpreting pharmacology data, using trial designs that compare multiple dosages, and safety and tolerability assessments to help determine the optimal doses of oncology drugs for pediatric patients.

Following a report of a serious grade 5 adverse event, the phase 1 PLAT-08 trial of SC-DARIC33 in pediatric patients with acute myeloid leukemia has been placed on hold

A time-based pathway to final analysis has been cleared by the FDA to evaluate the effect of uproleselan on relapsed/refractory acute myeloid leukemia.

Although dosing will continue in iMMagine-1 for patients who responded well to CART-ddBCMA, recruitment has been halted due to to a safety concern.

On the heels of an ASCO presentation of data from the phase 3 TALAPRO-2 trial, the FDA has granted approval to the study combination for the treatment of a metastatic castration-resistant prostate cancer subgroup.

Following positive data from the phase 3 IMerge study of imetelstat, the FDA has received a new drug submission for the agent for the treatment of patients with relapsed or refractory myelodysplastic syndrome.

Additional data have led to a full FDA approval for blinatumomab.

The phase 1 study is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of KT-253 monotherapy in patients with acute myeloid leukemias.

ADX-2191 will not be granted approval by the FDA due to the results of the phase 3 GUARD trial.

The phase 2b VIRAGE study will investigate the safety and efficacy of VCN-01 plus standard chemotherapy in patients with first-line pancreatic ductal adenocarcinoma.

A fast track designation has been granted by the FDA to quaratusugene ozeplasmid with atezolizumab for the treatment patients with extensive-stage small cell lung cancer.