Jordyn Sava

The disruption of the fine-tuned androgen receptor protein multivalent interactions might contribute to AR-related human pathologies.

Patients who are currently benefiting from lacutamab may continue to receive the treatment while the clinical hold is in place.

Additional findings from the phase 3 LIGHTHOUSE trial support flotufolastat F 18 injection and its approval in the prostate cancer space.

The FDA’s Oncologic Drug Advisory Committee met to discuss the supplemental new drug application for sotorasib for the treatment of adult patients with KRAS G12C mutated non–small cell lung cancer.

The CRCdx RAS mutation detection kit was designed to detect 35 variants of KRAS and NRAS exon 2, 3, and 4 somatic mutations in patients with colorectal cancer.

According to a follow-up survey by the National Comprehensive Cancer Network, 86% of cancer centers included are still experiencing oncology drug shortages.

Here is a lookback at all of the FDA happenings from September 2023.

BI 764532 is under investigation in a first-in-human phase 1 trial for patients with extensive-stage small cell lung cancer and extrapulmonary neuroendocrine carcinoma.

Midway through the IMMUNOCERV trial, PDS0101 enhances the production of versatile CD8 killer T cells, leading to reduced tumor DNA and significant tumor shrinkage of over 60% in all patients with high-risk cervical cancer.

Top-line results from a phase 2b trial evaluating FG001 for patients with high-grade glioma are expected by the end of November.

A phase 2 study of NT219 in combination with cetuximab for patients with second-line squamous cell carcinoma of the head and neck, is currently being designed.

Based on the recommendation of an independent data monitoring committee and positive topline data, accrual in the KMT2A-rearranged cohorts of the AUGMENT-101 trial of revumenib will be stopped.

In an interview, Nathan Bahary, MD, PhD, explains what factors have contributed to the rise in oncology drug shortages, and emphasizes the importance of proactive measures moving forward, while also suggesting the importance of policy changes and increased communication.

The FDA and Takeda have decided to voluntarily withdraw mobocertinib, a drug for patients with EGFR exon20 insertion mutation-positive non–small cell lung cancer.

The fast track designation for AVB-001 granted by the FDA recognizes its potential as a treatment option for patients with relapsed/refractory ovarian cancer.

In an interview with Targeted Oncology, Tanya B. Dorff, MD, discussed the role of goserelin and LHRH antagonists in the ever-changing treatment landscape for patients with prostate cancer.

In an interview with Targeted Oncology, Justin Taylor, MD, discussed early research on NX-2127, a BTK degrader being evaluated for the treatment of chronic lymphocytic leukemia.

Although response rates were lower among patients given previous anti-BCMA therapy, teclistamab shows promise for all patients with relapsed/refractory multiple myeloma.

In an interview with Targeted Oncology, Yael Schenker, MD, MAS, FAAHPM, discussed the importance of palliative care and advanced care planning for patients with advanced cancers.

In the first episode of Emerging Experts, Aakash Desai, MD, MPH, discusses his journey through the oncology field by reminiscing on the encouraging guidance of his mentors, personal research goals, and his experiences thus far as an oncologist.

Priority review to the biologics license application for odronextamab has been granted by the FDA for adult patients with follicular lymphoma and diffuse large B-cell lymphoma.

IDE161 now has 2 fast track designations from the FDA for patients with breast cancer and ovarian cancer. The agent continues to be evaluated in a first-in-human, phase 1 study for patients with advanced solid tumors.

Treatment with CAN-2409 produced promising survival data and continues to show a favorable safety and tolerability profile for the treatment of non-resectable, stage III/IV non–small cell lung cancer.

The ADVANCED-2 trial plans to build onto the early antitumor and safety data seen with TARA-002 that were presented this year for patients with non-muscle invasive bladder cancer.

Findings from the largest group of patients with BRCA1/2-altered metastatic castration resistant prostate cancer are now available.

In an interview, Chung-Han Lee, MD, PhD, discussed the challenges, studies, and outcomes previously observed when studying adjuvant treatments for patients with renal cell carcinoma.

Findings from a phase 1 support the fast track designation given by the FDA to IDE161, a potent, selective, small-molecule inhibitor of PARG, for patients with BRCA1/2 mutant ovarian cancer.

The FDA has issued a complete response letter for the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, but has not requested additional findings or clinical trials.

C. Ola Landgren, MD, PhD, discussed the ASCENT trial and his predictions for future developments in the myeloma space.

Responses from the FDA regarding questions submitted for a Type B pre-investigational new drug application meeting have provided a pathway for the start of a phase 2 trial of ropidoxuridine in glioblastoma.