Jordyn Sava

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.

Mark Geyer, MD, and Yannis K. Valtis, MD, delved into the background and findings from a study looking at clinical and laboratory tumor lysis syndrome in patients with CLL who were treated with venetoclax in the inpatient and outpatient settings.

JCXH-211, a first-in-class LNP-encapsulated self-replicating RNA encoding IL-12, demonstrates promising preclinical efficacy and safety for the treatment of patients with advanced solid tumors.

In an interview with Targeted Oncology, Francis P. Worden, MD, delved into the rationale behind the study and the implications of this research for patients with radioidine-refractory differentiated thyroid cancer.

The FDA has granted fast track designation to 225Ac-FL-020, a promising PSMA-targeting radionuclide drug conjugate for metastatic castration-resistant prostate cancer.

Combining stereotactic radiosurgery with immunotherapy significantly improves overall survival in patients with renal cell carcinoma and brain metastasis.

Here's a look back on all of the FDA happenings from June 2024.

In an interview, Cesar Augusto Perez, MD, delved into the findings from a phase 2 study evaluating petosemtamab plus pembrolizumab in patients with recurrent/metastatic head and neck squamous cell carcinoma.

Mikkael A. Sekeres MD, MS, further discussed the approval of imetelstat for the treatment of patients with low- to intermediate-1 risk myelodysplastic syndromes.

MRG004A, a novel antibody-drug conjugate, elicited antitumor activity and had manageable toxicities when used in heavily pretreated patients with multiple tumor types with high tissue factor.