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Here is your guide to all therapeutic options that were cleared by the FDA in June 2025 spanning tumor types.
FDA Approval Roundup: June
Below is your guide to all the oncologic therapeutic options that were cleared by the FDA in June 2025. The roundup provides everything you need to know, right at your fingertips—all the topline data that supported the decisions and expert insights contextualizing what they mean for clinical practice.
Indication: The FDA has approved darolutamide (Nubeqa) for use in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
Supporting Data: The decision was based on the phase 3 ARANOTE trial (NCT04736199), in which darolutamide plus ADT significantly improved radiographic progression-free survival (rPFS) compared with placebo plus ADT. The median rPFS was not reached vs 25.0 months (HR, 0.54; P < .0001), with consistent benefit across both high- and low-volume subgroups. Although overall survival was not significantly improved, darolutamide demonstrated clear benefit across several secondary end points, including time to metastatic castration-resistant prostate cancer, prostate-specific antigen (PSA) progression, and pain progression. The safety profile was consistent with prior experience and manageable.
Significance: This approval introduces a new therapeutic option in the mCSPC setting and supports the broader adoption of darolutamide earlier in the prostate cancer treatment continuum. In a recent interview with OncLive®, Fred Saad, CQ, MD, FRCS, FCAHS, of Centre Hospitalier de l’Université de Montréal, discussed the significance of the data:
Alicia Morgans, MD, MPH
Indication: The regulatory agency has approved taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC).
Supporting Data: The decision was based on findings from the phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials. In TKI-naive patients, the overall response rate (ORR) ranged from 85% to 90%, with a median duration of response (DOR) exceeding 44 months in TRUST-I. Among those previously treated with a ROS1 TKI, ORRs ranged from 52% to 62%, and the drug demonstrated robust intracranial activity. Across studies, taletrectinib showed a manageable safety profile, with elevated liver enzymes, gastrointestinal effects, and mild neurologic symptoms being the most common adverse effects (AEs).
Significance: This approval provides a new, brain-penetrant, next-generation ROS1 inhibitor with durable systemic and intracranial responses, offering a valuable option for both TKI-naive and previously treated patients with ROS1-positive NSCLC.
“[The FDA approval of taletrectinib] gives patients another option for treatment, which is really important,” Misako Nagasaka, MD, PhD, of University of California Irvine School of Medicine, said in a recent interview. “The drug has good coverage against a broad spectrum of ROS1 [mutations], excellent brain penetration, and a reasonable toxicity profile.”
Nathan A. Pennell, MD, PhD, of Taussig Cancer Institute of the Cleveland Clinic, further discussed the significance of the approval:
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Charu Aggarwal, MD, MPH
Indication: The FDA cleared a tablet formulation of zanubrutinib (Brukinsa) for use in all 5 previously approved indications of the capsule formulation, including mantle cell lymphoma after at least 1 prior therapy, Waldenström macroglobulinemia, relapsed/refractory marginal zone lymphoma after at least 1 anti-CD20 regimen, chronic lymphocytic leukemia/small lymphocytic lymphoma, and relapsed/refractory follicular lymphoma (FL) in combination with obinutuzumab after at least 2 prior lines of systemic therapy.
Supporting data: The new 160-mg tablets match the 320 mg daily dosing of the capsule formulation, simplifying administration from four capsules to two tablets per day. The most recent approval in FL was supported by findings from the phase 2 ROSEWOOD trial (NCT03332017), where the zanubrutinib/obinutuzumab (Gazyva) combination resulted in an ORR of 69% vs 46% with obinutuzumab alone (P = .0012), and a complete response (CR) rate of 39.3% vs 19.4% (P = .0035). The median DOR was not estimable with the combination and 14.0 months with obinutuzumab alone. The 18-month DOR rate was 69.3% vs 41.9%, respectively.
Significance: The tablet formulation of zanubrutinib offers a more convenient treatment option with the same efficacy and safety profile, which may improve patient adherence across a range of B-cell malignancies. The update builds on the agent’s growing role in hematologic oncology, particularly following recent success in relapsed/refractory FL.
“Brukinsa’s leadership in the United States underscores the trust physicians and patients have placed in its differentiated clinical profile,” Matt Shaulis, general manager of North America at BeOne, stated in a news release. “With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients facing certain B-cell cancers.”
Indication: The regulatory agency approved mitomycin intravesical solution (Zusduri; UGN-102) for the treatment of adult patients with recurrent, low-grade, intermediate-risk, non–muscle-invasive bladder cancer (NMIBC).
Supporting data: The decision was based on findings from the phase 3, single-arm ENVISION trial (NCT05243550), in which patients received six once-weekly instillations of UGN-102. The CR rate at 3 months was 79.6% (95% CI, 73.9%-84.5%), and the estimated 18-month DOR rate was 80.6% (95% CI, 74.0%-85.7%). Common AEs included dysuria, hematuria, urinary tract infection, and urinary retention. Serious AEs occurred in 12% of patients, with two events deemed treatment related. Despite a narrow 5-4 Oncologic Drugs Advisory Committee vote against the agent’s risk/benefit profile in May 2025, the FDA proceeded with approval.
Clinical significance: UGN-102 represents a novel, non-surgical therapeutic option for patients with recurrent, low-grade, intermediate-risk NMIBC, a population historically managed with repeated transurethral resections. Its approval marks a shift toward outpatient, chemoablative treatment strategies that may reduce the burden of repeated surgical interventions.
In a recent interview, William C. Huang, MD, of Tisch Hospital, NYU Langone Health, further discussed the clinical significance of the approval:
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Bogdana Schmidt, MD, MPH
Indication: The FDA approved pembrolizumab (Keytruda) as a single agent for neoadjuvant use, followed by adjuvant use in combination with radiotherapy with or without cisplatin, and continued as a single agent, for adult patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 with a combined positive score (CPS) of 1 or higher.
Supporting data: The decision was based on the phase 3 KEYNOTE-689 trial (NCT03765918), which enrolled patients with newly diagnosed, resectable stage III or IVA HNSCC. Among those with PD-L1 CPS of 1 or higher (n = 682), perioperative pembrolizumab significantly improved event-free survival (EFS) vs standard-of-care radiotherapy with or without cisplatin, with a median EFS of 59.7 months (95% CI, 37.9-not reached) vs 29.6 months (95% CI, 19.5-41.9), respectively (HR, 0.70; 95% CI, 0.55-0.89; P = .0014). The safety profile was consistent with prior pembrolizumab experience, with no new safety signals reported.
Clinical significance: This approval establishes the first perioperative immunotherapy option for patients with resectable, locally advanced PD-L1–positive HNSCC, supporting a new treatment paradigm aimed at reducing recurrence risk and improving long-term outcomes in a historically high-risk population.
“These results establish that…there’s a new standard of care for patients with locally advanced, resectable head and neck cancer [and] that is neoadjuvant pembrolizumab, followed by surgery and adjuvant pembrolizumab, given concurrently [with] and after radiotherapy or chemoradiotherapy,” Douglas R. Adkins, MD, of Washington University School of Medicine, Siteman Cancer Center, said in an interview with OncLive. “This is the first advancement…in treatment outcomes of patients with locally advanced head and neck cancer that is resectable in over 20 years.”
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Indication: The FDA approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) and rituximab (Rituxan) for adult patients with relapsed or refractory FL.
Supporting data: The approval was supported by results from the phase 3 inMIND trial (NCT04680052), which showed that the tafasitamab-based triplet significantly improved progression-free survival (PFS) compared with placebo plus lenalidomide and rituximab. At a median follow-up of 14.1 months, median PFS by investigator assessment was 22.4 months (95% CI, 19.2-not evaluable) vs 13.9 months (95% CI, 11.5–16.4), respectively (HR, 0.43; 95% CI, 0.32–0.58; P < .0001). Per independent review, median PFS was not reached in the tafasitamab arm vs 16.0 months in the control arm (HR, 0.41; 95% CI, 0.29-0.56). The safety profile included serious AEs in 33% of patients, with serious infections in 24%, and common toxicities such as cytopenias, fatigue, and rash.
Amitkumar Mehta, MD
Clinical significance: This marks the first FDA-approved CD19- and CD20-directed immunotherapy combination for follicular lymphoma and introduces a chemotherapy-free regimen with significant PFS benefit. The regimen provides a meaningful new option for patients with relapsed or refractory disease, including those with high-risk features, and may represent a new standard of care in this setting.
"The FDA recently approved tafasitamab in combination with rituximab and lenalidomide for the treatment of relapsed or refractory follicular lymphoma, providing a strong therapeutic option for this patient population," Amitkumar Mehta, MD, of the University of Alabama at Birmingham, said in an interview with OncLive. "If [we look] back 10 to 15 years ago, outcomes for patients [with relapsed/refractory follicular lymphoma] were very limited. However, with newer treatments such as bispecific antibodies and CAR T-cell therapy, treatment outcomes have significantly improved for patients with follicular lymphoma."
Christina Poh, MD
Indication: The FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Datroway; Dato-DXd) for adult patients with locally advanced or metastatic EGFR-mutated NSCLC who have previously received EGFR-directed therapy and platinum-based chemotherapy.
Supporting data: The decision was based on pooled efficacy findings from the phase 2 TROPION-Lung05 (NCT04484142) and phase 3 TROPION-Lung01 (NCT04656652) trials. Among 114 patients, the ORR was 45% (95% CI, 35%-54%) with a median DOR of 6.5 months (95% CI, 4.2-8.4). Additional pooled analyses reported a disease control rate of 86.3%, median PFS of 5.8 months, and median overall survival of 15.6 months. The safety profile was manageable, with grade 3 or higher treatment-related AEs occurring in 23% of patients, most commonly stomatitis, alopecia, and ocular surface events.
Clinical significance: Dato-DXd introduces a novel TROP2-directed antibody-drug conjugate (ADC) option for patients with EGFR-mutated NSCLC who have exhausted targeted and platinum-based therapies. Its activity in a heavily pretreated population highlights a meaningful advancement and fulfills an unmet need in the treatment landscape, especially given its manageable safety profile and encouraging response durability.
In an interview with Balazs Halmos, MD, of Montefiore Einstein Comprehensive Cancer Center, discussed the accelerated approval of Data-DXd in this population:
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Benjamin Levy, MD
On June 23, 2025, the FDA approved a label expansion for a kit of preparation of gallium Ga 68 gozetotide injection (Illuccix) to include its use in PET imaging patient selection for radioligand therapy in the pre-taxane setting in patients with metastatic castration-resistant prostate cancer.
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