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The regulatory decision is based on data from the phase 3 DESTINY-Breast09 results presented at the 2025 ASCO Annual Meeting.

Stereotactic body radiotherapy is less expensive and has demonstrated an improved safety profile vs immunotherapy and tyrosine kinase inhibitors.

Data from a Q-TWiST analysis of the LITESPARK-005 trial provide additional evidence for the use of belzutifan in those with advanced renal cell carcinoma.

The investigational agent showed particularly strong efficacy in an ES-SCLC subgroup, with a chemotherapy-free interval of 90 or more days.

With the recent approvals of T-DXd and Dato-DXd, the care for breast cancer continues to evolve and expand.

ODAC voted against the favorability of the agent in combination with dexamethasone and pomalidomide or bortezomib in multiple myeloma.

Phase 2b SunRISe-1 trial findings supported the FDA to grant priority review to TAR-200 in BCG-unresponsive high-risk NMIBC with carcinoma in situ.

Particularly strong efficacy signals were observed in patients with non-squamous non–small cell lung cancer previously treated with PD-1 inhibition.

Paolo Tarantino, MD, PhD, discusses sequencing ADCs, managing cross-resistance, and understanding ADC composition for patients with breast cancer.

Erika Hamilton, MD, gave an overview of evolving therapies and recent trial updates for patients across breast cancer subtypes.

Combining ADCs has shown a potential improvement in survival, but it may also come with increased toxicities.

No dose-limiting toxicities or unexpected adverse effects occurred with carotuximab/apalutamide in metastatic castration-resistant prostate cancer.

Transarterial chemoembolization plus sorafenib did not significantly improve overall survival in advanced hepatocellular carcinoma vs sorafenib alone.

The FDA has asked tambiciclib’s developer to start a trial investigating the combination in front-line acute myeloid leukemia.

Investigators are evaluating ZEN-3694 in combination with abemaciclib or cisplatin/etoposide across 2 clinical trials in NUT carcinoma.

Cross-resistance makes it important to determine sequencing options across antibody-drug conjugates for patients with breast cancer.

Patients with node-negative disease who are older and have comorbidities may not be suitable to receive CDK4/6 inhibitors.

Relacorilant plus nab-paclitaxel led to a median PFS and OS of 6.54 months and 15.97 months, respectively, in patients with platinum-resistant ovarian cancer.

The confirmed objective response rate among 56 patients with extensive-stage small cell lung cancer was 87.5%, all of whom experienced partial responses.

The FDA lifted a clinical hold on a new drug application for tabelecleucel as a treatment for EBV-positive lymphoproliferative disease in May 2025.

Heather McArthur, MD, focused on current and future strategies for treating early-stage breast cancer.

An observed carryover effect with CDK4/6 inhibitors may reduce the risk of recurrence years after a patient stops treatment.

Among 115 patients treated with avutometinib and defactinib, only 5 deaths occurred in the study, none of which were related to study treatment.

In a discussion at IBC East, Heather McArthur, MD, highlighted how immunotherapy is being utilized for patients with early-stage breast cancer.

Phase 1b data show antitumor activity with the givastomig combination across a wide range of CLDN18.2 expression.

Results from a phase 2 study showed a median OS of 10.2 months in all patients with small cell lung cancer who received stereotactic radiation therapy.

The B7-H3–low and TIGIT-high biosignatures correlated with superior event-free survival outcomes in those with melanoma treated with the combination.