Jordyn Sava

An investigational new drug application for VIPER-101, a chimeric antigen receptor T-cell therapy, has been cleared by the FDA in T-cell lymphoma.

A dual primary end point of progression-free survival in the phase 3 CheckMate-8HW trial evaluating nivolumab and ipilimumab in metastatic colorectal cancer has been met.

The FDA has granted 2 designations to cretostimogene grenadenorepvec, an oncolytic immunotherapy, for the treatment of a specific type of high-risk bladder cancer:

In an interview with Targeted Oncology, Edward B. Garon, MD, MS, discussed the ever-changing treatment landscape for EGFR-mutated lung cancer, as well as the unmet needs and potential next steps for research in this space.

In the first 3 cleared monotherapy cohorts of the VISTA-101 trial, KVA12123 showed promising safety and pharmacokinetics with a sign of efficacy across patients with advanced solid tumors.

An experimental drug combination of inavolisib, palbociclib, and fulvestrant significantly improved progression-free survival in patients with HR-positive/HER2-negative PIK3CA-mutated breast cancer.

CT071, a chimeric antigen receptor T-cell therapy candidate, had an investigational new drug application cleared by the FDA for patients with relapsed/refractory multiple myeloma and primary plasma cell leukemia.

A phase 1 trial plans to be initiated in 2024 to investigate GTB-3650 for the treatment of patients with CD33-positive leukemia.

A patient with prostate cancer in the SECuRE trial treated with 2 cycles of 67Cu-SAR-bisPSMA at the 8GBq dose level has achieved undetectable prostate specific antigen levels.

In an interview with Targeted Oncology, Neeraj Agarwal, MD, discussed findings from the TITAN trial which were presented at ESMO 2023.

Here is a look back at the FDA happenings from the month of November 2023.

A report suggests the cause behind different outcomes among patients with diffuse large B-cell lymphoma who relapse, highlighting that patients whose cancer relapses shortly after treatment tend to have worse responses to additional chemotherapy-based treatment.

Positive data from the phase 3 EV-302 trial of enfortumab vedotin with pembrolizumab in locally advanced or metastatic urothelial cancer have shifted the landscape.

Matthew Hadfield, DO, discusses his passion for early-stage clinical trials and the need for more research into immunotherapy toxicities during the third episode of Emerging Experts.

More work is needed in the community oncology setting to improve barriers to care and enrollment in clinical trials which are often due to geographic location, awareness, and eligibility criteria.

Based on in vitro data, pacritinib led to a 4-fold higher potency for inhibition of the hepcidin regulator ACVR1 vs momelotinib among patients with cytopenic myelofibrosis and led to an increase in red blood cell transfusion independence.

Telisotuzumab vedotin demonstrated promising efficacy and safety in patients with advanced nonsquamous non–small cell lung cancer with high or intermediate c-Met expression.

CT-0525 is an ex vivo gene-modified autologous CAR-monocyte cellular therapy being evaluated for the treatment of HER2-overexpressing solid tumors.

The potential of CTLA4 deletion as a strategy to improve chimeric antigen receptor T-cell efficacy was observed in a study published in Immunity.

A fast track designation has been granted to zotatifin with fulvestrant, and abemaciclib for adult patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer.

Nirogacestat is now an FDA-approved option for adult patients with progressing desmoid tumors who require systemic treatment.

The biologics license application seeking the approval of obe-cel as a potential therapeutic option in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia has been submitted to the FDA.

In an interview with Targeted Oncology, Lisa B. Ercolano, MD, discussed the evolving treatment landscape for sarcomas and underscored the pivotal role of molecular profiling, while addressing the need for more efficacious systemic therapies.

An investigational new drug application for TCB008 has been cleared by the FDA. A phase 1B trial will now assess the agent in patients with relapsed/refractory acute myeloid leukemia.

In addition to the approval of capivasertib and fulvestrant, the FDA has granted approval to the FoundationOne® CDx as a companion diagnostic to identify patients with advanced HR-positive, HER2-negative advanced breast cancer.

The rate of undetectable minimal residual disease at 10-4 in bone marrow was 77%, including a 71% rate among 14 patients with chronic lymphocytic leukemia refractory to prior Bruton tyrosine kinase inhibitors treated with venetoclax, umbralisib, and ublituximab.

VBI-1901 10µg plus GM-CSF had a disease control rate of 44% among 16 patients with recurrent glioblastoma in a phase 1/2a study.

Along with improvements shown for the primary and secondary end points of the phase 3 MANIFEST-2 trial in JAK inhibitor-naive patients with myelofibrosis, pelabresib plus ruxolitinib did not display any new safety signals.

In an interview with Targeted Oncology, Michael Wang, MD, discussed the rationale of the phase 3 study and how positive results from this trial may further shape the mantle cell lymphoma treatment landscape.