Jordyn Sava

The first pretreated patient with HER2-altered non–small cell lung cancer was dosed with NVL-330, a novel HER2-selective inhibitor, in the HEROEX-1 trial.

The FDA has granted a fast track designation to ozuriftamab vedotin for treating recurrent/metastatic head and neck cancer that progressed after prior therapies.

TLX007-CDx, if approved by the FDA, has the potential to become a new PSMA PET imaging agent for prostate cancer.

The FDA has approved an individual patient investigational new drug application, allowing for a second dose of a novel CAR T-cell therapy for a patient with recurrent ovarian cancer.

Small cell lung cancer poses a significant challenge across the world, particularly in low-middle-income countries where it is often associated with poor outcomes.

Agenus was advised by the FDA against filing for accelerated approval of botensilimab plus balstilimab for relapsed/refractory microsatellite stable metastatic colorectal cancer without liver metastases.

As the clinical utility of ctDNA continues to be assessed, it is becoming a valuable tool for various cancer types, including gastrointestinal cancers, blood cancers, and other solid tumors.

The primary end point of increasing progression-free survival was not met in the TiNivo-2 trial in patients with advanced metastatic renal cell carcinoma.

A phase 1 trial is underway to assess the safety and efficacy of BTX-9341, a novel investigational oral degrader of CDK4/6 in HR-positive/HER2-negative breast cancer.

Mark D. Tyson, II, MD, MPH, discussed treatment with cretostimogene grenadenorepvec in high-risk Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ and data from the BOND-003 trial.

7MW3711, an innovative antibody-drug conjugate targeting B7-H3, has been granted an orphan drug designation by the FDA for treating small cell lung cancer.

Taiga Nishihori, MD, discussed the current outpatient administration model of cilta-cel among patients with relapsed/refractory multiple myeloma.

The FDA has granted a rare pediatric disease designation to SLS009 for treating pediatric acute myeloid leukemia.

In an interview, Aniket Bankar, MD, discussed the background, design, and goals of the phase 3 VERIFY trial of the hepcidin mimetic rusfertide for the treatment of patients with polycythemia vera.

Following the report of a serious and unexpected grade 4 adverse effect, a partial clinical hold has been placed on the phase 1 trial evaluating seclidemstat with azacitidine in myelodysplastic syndrome and chronic myelomonocytic leukemia.

The FDA has received the submission of an investigational new drug application for a phase 1/2 trial evaluating the combination of silmitasertib and chemotherapy in relapsed/refractory solid tumors.

In this episode of Targeted Talks, Omid Hamid, MD, discusses data supporting the use of lifileucel for the treatment of advanced melanoma.

The FDA granted a fast track designation to DSP-5336 in relapsed/refractory AML with a KMT2A rearrangement or NPM1 mutation, showing promising results and safety in early trials.

The ESOGUARD BE-1 trial demonstrated that the EsoGuard test, combined with EsoCheck, effectively detects esophageal precancer and supports its use as a screening tool to prevent esophageal cancer.

In an interview with Targeted Oncology, Ali Duffens, MD, discussed findings from a study which investigated detecting breast cancer recurrence among women treated at Kaiser Permanente Northern California.

A fast track designation has been granted to OBX-115, a TIL cell therapy for the potential treatment of patients with advanced melanoma.

In an interview, Aakash Desai, MD, MPH, discussed significant lung cancer treatment advancements that were highlighted at ASCO 2024.

The FDA has received a 505(b)(2) new drug application seeking approval for a lutetium Lu 177 dotatate injection as a potential treatment for SSTR-positive gastroenteropancreatic neuroendocrine tumors.

A phase 2 trial demonstrated that nivolumab is effective and has a manageable safety profile in patients with mismatch repair deficiency uterine or ovarian cancers.

The first patient with metastatic sarcoma in the US has been treated with INT230-6 alone in the phase 3 INVINCIBLE-3 study.

The completion of the End of Phase 2 meeting for the phase 1B/2 trial of annamycin and cytarabine in acute myeloid leukemia has been announced.

Mark Geyer, MD, and Yannis K. Valtis, MD, discussed real-world findings on the incidence, prevention, and management of tumor lysis syndrome in patients with CLL treated with venetoclax.

The FDA has granted fast track designation to ADI-270, an off-the-shelf CD70-targeted gamma delta CAR T-cell therapy, for treating metastatic or advanced clear cell renal cell carcinoma.

BNT324/DB-1311 gained fast track designation from the FDA in unresectable advanced or metastatic castration-resistant prostate cancer who have progressed after standard treatments.

A phase 1/2 trial evaluating DSP-5336 for the treatment of patients with acute leukemia harboring either an NPM1 mutation or KMT2A rearrangement showed early response rates.