Jordyn Sava

Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.

In an interview with Targeted Oncology, Mark R. Litzow, MD, discussed the incorporation of Immunotherapy into upfront acute lymphoblastic leukemia treatment.

In an interview with Targeted Oncology, Sergio A. Giralt, MD, discussed the evolving role of transplant in myelodysplastic syndromes.

The REMARK trial aims to assess the safety and efficacy of RVU120 in patients with lower-risk myelodysplastic syndromes.

The phase 2 BRACELET-1 trial demonstrated that the combination of pelareorep and paclitaxel significantly improved outcomes for patients with HR-positive/HER2-negative metastatic breast cancer.

CF33-hNIS has gained FDA orphan drug designation for the treatment of cholangiocarcinoma and is currently being evaluated in the phase 1 MAST trial.

The field of Hodgkin lymphoma is undergoing significant advancements, with new drugs entering the frontline and personalized treatment approaches emerging.

Pembrolizumab plus chemotherapy is now an approved frontline treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma.

Adjuvant ribociclib plus an aromatase inhibitor is now an FDA-approved treatment in HR-positive, HER2-negative stage II and III early breast cancer at a high risk of recurrence.

In this episode of Targeted Talks, James M. Foran, MD, discusses the presentation and diagnosis of blastic plasmacytoid dendritic cell neoplasm.

Superior efficacy at 12 weeks was seen with the frontline combination of abemaciclib and endocrine therapy vs standard chemotherapy in patients with advanced breast cancer.

Following promising preliminary findings from a phase 1 study, the FDA granted P-BCMA-ALLO1 regenerative medicine advanced therapy designation in relapsed/refractory multiple myeloma.

RP1 with nivolumab treatment for patients with melanoma after progression on anti–PD-1 offers durable responses and a favorable safety profile, as shown in the IGNYTE study.

Naomi Dempsey, MD, discussed developments in the HER2-positive breast cancer space, including personalized approaches, less toxic treatments, promising trial results, and more.

The investigational new drug application for VNX-101, a gene therapy aimed at treating CD19-positive acute lymphoblastic leukemia, has been approved by the FDA.

The FDA granted orphan drug designation for elraglusib, a novel drug for treating advanced soft tissue sarcoma.

HER2DX has shown a strong association between ERBB2 mRNA and survival in patients with HER2-positive breast cancer.

In this preview, we highlight the key late-breaking abstracts to be presented at the 2024 ESMO Congress across various tumor types that may impact clinical practice.

Pretreatment with dexamethasone significantly reduced infusion-related reactions in patients receiving amivantamab for advanced lung cancer, according to findings from the SKIPPirr study.

Denileukin diftitox, an IL-2-receptor-directed cytotoxin, has been added to the NCCN guidelines for the treatment of adult patients with cutaneous T-cell lymphoma.

Craig A. Portell, MD, previews his session on sequencing therapies in relapsed/refractory mantle cell lymphoma being presented at the 2024 Society of Hematologic Oncology Annual Meeting.

Here is a look back on all the FDA happenings from the month of August 2024.

In an interview, Jaime Merchan, MD, explained the background and data from a biomarker analysis of the CLEAR trial in advanced renal cell carcinoma.

Mayra Shanley, PhD, discussed background and future directions for evaluating IL-21 natural killer cells for the treatment of glioblastoma.

NXP800 was granted orphan drug designation from the FDA in ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.

In this episode of Emerging Experts, Paolo Tarantino, MD, discusses the latest developments in breast cancer research and treatment.

The phase 3 SOHO-02 trial has enrolled its first patient with advanced non–small cell lung cancer harboring activating HER2 mutations.

A new drug application for TLX101-CDx, an investigational PET imaging agent designed to differentiate progressive or recurrent glioma from treatment-related changes, has been submitted to the FDA.

In an interview, Anil Parwani, MD, PhD, discussed how artificial intelligence can be used in medical education and training, as well as its role in personalized medicine.

New data on zongertinib for HER2-positive non–small cell lung cancer will be presented at the IASLC 2024 World Conference on Lung Cancer, shedding light on its potential as a novel treatment option for this patient population.