Jordyn Sava

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.

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.

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.

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.

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.

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

The phase 2b REZILIENT1 trial of zipalertinib in EGFR+ non–small cell lung cancer met its overall response rate primary end point with a consistent safety profile.

MB-105, a first-in-class CD5-targeted CAR T-cell therapy, received FDA orphan drug designation for relapsed/refractory T-cell lymphoma.

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

The phase 3 INVINCIBLE-3 study of INT230-6 for soft tissue sarcomas continues without changes following Data Monitoring Committee safety review.

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, based on phase 3 DESTINY-Breast06 trial results.

The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in patients with biochemical recurrence following definitive therapy.

Patients with AML aged 80 years and older face poor survival despite treatment advances, highlighting the need for improved, equitable care strategies and tailored treatment approaches.

The CheckMate 9DW study demonstrated the efficacy and manageable safety of first-line nivolumab plus ipilimumab in patients with unresectable hepatocellular carcinoma.

The combination of treosulfan and fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia or myelodysplastic syndromes has been approved by the FDA.

The phase 3 REGAL trial of galinpepimut-S in acute myeloid leukemia can proceed without modifications, based on findings from the prespecified interim analysis of the study.

The FDA has granted breakthrough therapy designation to the DCISionRT test, a tool that assesses radiation therapy benefit for women aged 30 to 85 with ductal carcinoma in situ.

Pending phase 3 trial results, a biologics license application will be submitted for the KRAS-targeting cancer vaccine ELI-002.

The CELESTIAL-301 trial evaluating SynKIR-310, a novel CAR T-cell therapy, has dosed its first patient with relapsed/refractory B-cell non-Hodgkin lymphoma.

The first patient with relapsed/refractory acute myeloid leukemia has received KJ-C2320, an allogeneic CAR T-cell therapy targeting CD38 and developed using the THANK-uCAR platform, in an investigator-initiated trial in China.

Elinzanetant reduced vasomotor symptoms frequency and severity in women with or at high risk of HR-positive breast cancer in the OASIS 4 trial.

Here are the most anticipated abstracts to keep an eye on going into the 2025 ASCO Gastrointestinal Cancers Symposium.

The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the FDA with priority review.

Molecular oncology is revolutionizing cancer care by using genetic profiling to tailor personalized treatments, improving efficacy, minimizing adverse events, and paving the way for advanced therapies.

In an interview, Paolo Ghia, MD, PhD, discussed updated data from the phase 2 CAPTIVATE trial of ibrutinib and venetoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma.