The OncFive: Top Oncology Articles for the Week of 7/6

July 12, 2025

The FDA approves Y-90 resin microspheres in HCC, the sNDA for decitabine/cedazuridine plus venetoclax in AML is under review, and more.

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

FDA Approves Y-90 Resin Microspheres for Unresectable HCC

The FDA has approved SIR-Spheres® Y-90 resin microspheres for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who meet specific criteria, including Child-Pugh A cirrhosis, no macrovascular invasion, and good performance status. The decision was supported by data from the phase 2 DOORwaY90 trial (NCT04736121), which demonstrated an overall response rate of 98.5% and a local tumor control rate of 100% among evaluable patients. The median duration of response exceeded 300 days. The study also showed that the therapy had a favorable toxicity profile and reproducible dosimetry. This decision expands the indication for SIR-Spheres beyond metastatic colorectal cancer (CRC), making it the only Y-90–based therapy approved in the United States for both CRC and HCC. The resin microspheres deliver targeted internal radiation to tumors while minimizing exposure to healthy liver tissue, offering a non-surgical treatment option for appropriately selected patients.

Decitabine/Cedazuridine Plus Venetoclax sNDA Under FDA Review for Newly Diagnosed AML

The FDA has accepted a supplemental new drug application (sNDA) for decitabine and cedazuridine (Inqovi) in combination with venetoclax (Venclexta) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. The submission is based on data from the phase 2b ASCERTAIN-V trial (NCT04657081), which showed a complete response (CR) rate of 46.5% and a CR/CR with incomplete hematologic recovery rate of 63.4%, with durable remissions and consistent efficacy observed across subgroups. Moreover, the median overall survival in the trial was 15.5 months, with encouraging early durability of response. The all-oral combination also had a manageable toxicity profile with no new safety signals. Pharmacokinetic data confirmed no drug-drug interactions. If approved, the regimen would become the first all-oral option for this patient population, potentially offering a more accessible and less intensive alternative.

FDA Releases CRLs for Previous Drug and Biologic Product Applications

The FDA has released an initial set of 202 complete response letters (CRLs), including 32 related to oncology, marking a significant step toward greater transparency in regulatory decision-making. These CRLs—many tied to applications submitted between 2020 and 2024—highlight common issues that have previously delayed or blocked drug approvals, including safety, efficacy, and manufacturing deficiencies. The letters are now publicly accessible at open.fda.gov, although redacted to protect confidential information. Notably, several CRLs included in this batch were later followed by successful approvals, such as sodium thiosulfate (Pedmark), toripalimab-tpzi (Loqtorzi), denileukin diftitox-cxdl (Lymphir), and zolbetuximab-clzb (Vyloy), underscoring the importance of addressing concerns identified by the regulatory agency. According to FDA Commissioner Marty Makary, MD, MPH, the move is intended to provide more predictability for sponsors and accelerate patient access to needed therapies.

Enzalutamide Plus Leuprolide Yields OS Benefit in nmHSPC With Biochemical Recurrence

The phase 3 EMBARK trial (NCT02319837) has shown that enzalutamide (Xtandi) plus leuprolide significantly improves overall survival (OS) vs placebo plus leuprolide in patients with nonmetastatic hormone-sensitive prostate cancer (nmHSPC) and high-risk biochemical recurrence. Although enzalutamide monotherapy also trended toward improved OS, the difference was not statistically significant. Previously published data from the trial showed that enzalutamide-based regimens significantly improved metastasis-free survival, leading to FDA approval in November 2023 for patients with nmCSPC and high-risk biochemical recurrence. No new safety concerns were observed; fatigue and hot flashes were among the most common adverse events. These new OS findings further support early initiation of enzalutamide in this high-risk patient population.

Pexidartinib Shows Long-Term Safety and Efficacy in Symptomatic TGCT

Final long-term results from the open-label extension of the phase 3 ENLIVEN trial (NCT02371369) showed that pexidartinib (Turalio) delivered sustained clinical benefit in patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to surgery. At a median follow-up of 31.2 months, the overall response rate was 60% by RECIST 1.1 criteria and 68% by tumor volume score, and the median duration of response was not reached. These data reinforce the durable efficacy observed in the trial's initial analysis, which supported the agent’s FDA approval in 2019 as the first systemic therapy for TGCT. The treatment’s safety profile remained consistent with earlier reports, with elevated liver enzymes and hypertension among the most common grade 3 or higher adverse effects. These final data highlight the long-term potential of pexidartinib for patients with advanced TGCT and limited surgical options.