Jordyn Sava

NUV-1511, a novel drug candidate for the treatment of solid tumors, has received clearance from the FDA for its investigational new drug application.

The FDA has issued a complete response letter to the biologics license application of zolbetuximab for patients with advanced, HER2-negative, claudin 18.2-positive gastric or gastoesophageal junction adenocarcinoma.

A Safe to Proceed letter from the FDA has been granted to the investigational new drug application of a phase 2 study evaluating ropidoxuridine plus radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma.

Haifa Kathrin Al-Ali, MD, discussed findings from the phase 1/2 CA011-023 study of BMS-986158 combined with ruxolitinib or fedratinib in myelofibrosis.

Iopofosine I-131 showed impressive results in a study for patients with advanced Waldenstrom's macroglobulinemia, achieving a major response rate of 61%.

Bradley J. Monk, MD, FACS, FACOG, discusses the enrollment criteria and dosing for the phase 3 KEYNOTE-A18 study of patients with newly diagnosed, previously untreated, high-risk locally advanced cervical cancer.

In an interview with Targeted Oncology, Ann LaCasce, MD, MMSc, delved into the surge of innovations with personalized medicine, advanced technologies, and novel agents for the treatment of patients with lymphomas.

The phase 2 DisTinGuish study is evaluating the combination of DKN-01, tislelizumab, and chemotherapy for the first-line treatment of patients with advanced gastroesophageal adenocarcinoma.

Rinatabart sesutecan is an antibody drug conjugate that has now received a fast track designation from the FDA for the treatment of FRα-expressing ovarian cancer.

Two PD-L1 tests, SP263 and 22C3, show high agreement & effectively identify patients with early-stage non–small cell lung cancer who are likely to benefit from adjuvant atezolizumab.

In an interview with Targeted Oncology, Andre Goy, MD, discussed the potential of brexucabtagene autoleucel for the treatment of patients with relapsed/refractory mantle cell lymphoma and how 2 studies provide support for use of the agent in this patient population.

The completion of the phase 1 trial is a crucial step toward making DOC1021 available to all patients with glioblastoma multiforme.

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

In a phase 1 study of 10 evaluable patients with refractory/relapsed malignant pleural mesothelioma, the median overall survival was 17.6 months for patients treated with the combination of galinpepimut-S and nivolumab.

In an interview with Targeted Oncology, Francis P. Worden, MD, shed light on the evolving landscape of advanced thyroid cancer treatment, offering valuable insights into the available options.

The phase 1/2 CaRe PC trial evaluating INKmune, a biologic therapy, in male patients with metastatic castration-resistant prostate cancer has dosed its first patient.

In an interview with Targeted Oncology, James Zou, PhD, provided an overview of AI and machine learning applications in oncology.

In an interview with Targeted Oncology, Jennifer A. Woyach, MD, discussed updated results from the phase 1/2 BRUIN study of pirtobrutinib in chronic lymphocytic leukemia or small lymphocytic lymphoma following treatment with a covalent Bruton tyrosine kinase inhibitor.

In an interview with Targeted Oncology, Daniel Baker, PhD candidate at the University of Pennsylvania, discussed the growing role for CAR T-cell therapies outside of the oncology field.

Andrew Srisuwananukorn, MD, assistant professor at The Ohio State University Comprehensive Cancer Center, discussed the use of a novel artificial intelligence model that aids in the differentiating between prefibrotic primary myelofibrosis and essential thrombocythemia.

In an interview with Targeted Oncology, Marcelen Rosenscheg, MD, discussed some of the methods that are used to treat pain in patients with cancer and the importance of such research.

The FDA is considering 2 applications for amivantamab plus lazertinib as a first-line treatment for EGFR-mutated non–small cell lung cancer, based on the phase 3 MARIPOSA study.

In an interview with Targeted Oncology, Igor Astsaturov, MD, PhD, discussed what led to the development of LP-184 and explained how the agent will be evaluated moving forward.

A phase 1 study investigating padeliporfin vascular targeted photodynamic in patients with unresectable pancreatic adenocarcinoma will begin following the FDA clearance of an investigational new drug application.

In an interview with Targeted Oncology, Yazmin Odia, MD, discussed the 3rd Annual Miami Cancer Institute Oncology Rehabilitation Symposium, including her discussion on incorporating rehabilitation into the course of treatment for patients with brain cancer.

The FDA has granted clearance to a promising new agent, AVS100, for a phase 1 trial to target solid tumors.

The FDA has issued a complete response letter which will delay the potential approval of cosibelimab for patients with cutaneous squamous cell carcinoma.

A cohort study highlighted the racial and ethnic survival disparities that exist among patients with early breast cancer who are being treated with standardized initial care.

Though the combination of talazoparib and avelumab was safe as a treatment for patients with specific types of kidney cancer, the combination was not effective, according to findings from a phase 2 trial.

Positive headline results from part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO trial support the potential use of dostarlimab as the backbone for therapies in mismatch repair proficient/microsatellite stable primary advanced or recurrent endometrial cancer.