News

David Sallman, MD, discusses using eprenetapopt and azacitidine in TP53-mutant myelodysplastic syndrome and acute myeloid leukemia post-allogeneic stem cell transplantation.

The FDA granted RMAT status to gemogenovatucel-T for maintenance in patients with advanced ovarian cancer.

In this episode of Targeted Talks, Aditya Bardia, MD, MPH, FASCO, discusses the recent FDA approval of datopotamab deruxtecan in breast cancer.

Here is a look back on all the FDA happenings from the month of January 2025.

A phase 1 study of a personalized cancer vaccine demonstrated antitumor immunity in all treated patients with resected renal cell carcinoma.

The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its prior HER2-low indication.

FDA reviews biologics license application for HLX11, a biosimilar to pertuzumab, for HER2-positive breast cancer.

Andrea Roman, PharmD, BCOP, US Oncology Network and McKesson, discussed the integration of clinical pharmacists into community oncology practices.

Ann LaCasce, MD, MMSc, director of the Dana-Farber/Massachusetts General Brigham Fellowship in Hematology/Oncology, highlights the role of bispecific antibodies in lymphoma research.

Azenosertib monotherapy showed a 34.9% overall response rate in heavily pretreated, cyclin E1–positive, platinum-resistant ovarian cancer, with a median duration of response of 5.5 months.

In an interview with Targeted Oncology for World Cancer Day, Manmeet Ahluwalia, MD, MBA, FASCO, explored the key challenges facing community oncology and the strategies needed to close these gaps.

Marwan G. Fakih, MD, discussed the implications of the findings from the phase 2 study for patients with microsatellite stable metastatic colorectal cancer without liver metastases.

Marwan G. Fakih, MD, explains the implications of the findings from the phase 2 trial of balstilimab plus botensilimab for the treatment of patients with microsatellite stable metastatic colorectal cancer without liver metastases.

Data from the phase 3 ENVISION trial demonstrate the potential of UGN-102 as an effective and durable nonsurgical treatment for patients with low-grade, intermediate-risk non–muscle-invasive bladder cancer.

T-DM1 was tolerable in HER2-positive biliary tract adenocarcinoma but did not significantly improve progression-free survival.

For Heart Health Month, Amy Ahnert, MD, Director, Women’s Heart Program at Morristown Medical Center, Atlantic Health System, discussed the link between cardiovascular disease and breast cancer.

Marwan G. Fakih, MD, provides an overview of the study design, rationale, and findings from a phase 2 trial of balstilimab with botensilimab for the treatment of patients with microsatellite stable metastatic colorectal cancer without liver metastases.

Aspirin reduced recurrence by 50% in PIK3CA-mutated colorectal cancer, the DCISionRT test earned FDA breakthrough status for predicting radiotherapy benefit in DCIS, and nivolumab plus chemotherapy sustained efficacy in gastric/GEJ/esophageal cancers. We also provide an overview of key abstracts from ASCO GI and molecular oncology and how it is changing care.

Ashraf Z. Badros, MB, ChB, discusses the next steps following the phase 3 AURIGA trial of daratumumab and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma.

Bevacizumab's survival benefits in CRC patients persist for about 2 years after starting treatment.

Ann LaCasce, MD, MMSc, delved into some of the most recent advances in the lymphoma space, exploring how these new therapies are offering hope for more durable remissions and better quality of life.

Susumu Hijioka, MD, discusses the key takeaways from the phase 3 STARTER-NET trial evaluating the combination of everolimus with lanreotide when used for the first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

Patients with BRAF V600E-mutant metastatic colorectal cancer experienced poor clinical outcomes with systemic therapy, according to real-world data.

A "watch and wait" strategy after total neoadjuvant therapy showed similar outcomes and safety to total mesorectal in stage II/III rectal cancer.

Daniel Rubin, PharmD, BCOP, discussed a study showing how a clinical decision support tool can improve the documentation of biomarker results in cancer care.

Alexander I. Spira, MD, PhD, FACP, discusses the next steps in the clinical development of zoldonrasib for patients with KRAS G12D pancreatic ductal adenocarcinoma based on preliminary findings.

Early palliative care reduces invasive interventions and enhances comfort at EOL for CRC patients, according to real-world study results.

The LumiSystem detection tool is now commercially available in the US.

The use of radiation therapy has become a staple in breast cancer treatment, with benefits seen in node-positive patients, those with locally advanced disease, and those with large-sized tumors.

Alexander I. Spira, MD, PhD, FACP, discusses the clinical implications of ctDNA for treatment decisions and monitoring in patients with KRAS G12D pancreatic ductal adenocarcinoma treated with zoldonrasib.