News

The FDA has accepted the resubmitted application of remestemcel-L, a potential first-of-its-kind treatment for pediatric patients following stem cell transplants.

The tyrosine kinase inhibitor entrectinib shows promising responses in patients with non–small cell lung cancer harboring a ROS1 mutation.

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.

AIC100 now has a regenerative medicine advanced therapy designation from the FDA for the treatment of recurrent anaplastic thyroid cancer.

An analysis from the innovaTV 301 showed that tisotumab vedotin in the second- and third-line bettered overall survival vs investigator’s choice of chemotherapy in patients with cervical cancer.

Clinical development of ZW191 is planned to begin in the second half of 2024.

Amivantamab/lazertinib trumps osimertinib in lung cancer treatment, promising results with nivolumab in dMMR in gynecologic cancers, and Curium’s lutetium-177 submission for SSTR-positive GEP-NETs are featured. Regarding lung cancer, we also cover valuable insights on immunotherapy combinations and breakthrough treatments presented at ASCO.

Taiga Nishihori, MD, discusses a study in which investigators evaluated patients with relapsed/refractory multiple myeloma who were hospitalized and treated with commercial ciltacabtagene autoleucel at Moffitt Cancer Center between May 2022 and May 2023.

Robert Jotte, MD, PhD, discussed findings from the phase 3 KRYSTAL-12 study evaluating adagrasib vs docetaxel in previously treated KRAS G12C-mutated non–small cell lung cancer.

Adam C. Berger, MD, FACS, highlights the challenges and advancements in diagnosing and treating sarcoma, a rare and diverse group of cancers originating from mesenchymal tissues.

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.

Patients who underwent hematopoietic cell transplantation had similar outcomes with matched vs mismatched unrelated donors when posttransplant cyclophosphamide was used.

Alexandra Gomez Arteaga, MD, discusses the rationale behind a retrospective study comparing Orca-T with posttransplant cyclophosphamide-based hematopoietic cell transplantation.

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.

During a Case-Based Roundtable® event, Andrew Yee, MD, discussed the use of carfilzomib-based regimens compared with other options for patients with multiple myeloma, including those refractory to lenalidomide in the first article of a 2-part series.

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.

Findings from the phase 3 ARANOTE trial demonstrated an improvement in radiographic progression-free survival with darolutamide vs placebo plus androgen deprivation therapy in metastatic hormone-sensitive prostate cancer.

Francis P. Worden, MD, discusses future plans to investigate combination therapies and other novel treatments in the thyroid cancer space.

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.

A dendritic cell vaccine called DOC1021 shows early promise in treating pancreatic cancer and has received a fast track designation from the FDA.

Ajaz M. Khan, MD, MBA, CPE, provides his insights into the novel biomarkers and up-front immunotherapies that are changing the landscape of treatment for patients with lung cancer.

Elias Jabbour, MD, provides an overview of the significance of the FDA approval of ponatinib plus chemotherapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic 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.

A new study suggests a short course of immunotherapy before surgery may significantly improve outcomes in patients with high-risk melanoma.