OncLive’s October Roundup of Key FDA Approvals in Oncology: 4 Decisions to Know

Below is your guide to all the oncologic therapeutic options that were cleared by the FDA in October 2025. The roundup provides everything you need to know, right at your fingertips—all the topline data that supported the regulatory decisions and expert insights detailing what they mean for clinical practice.

10/2: Lurbinectedin Plus Atezolizumab for Frontline Maintenance in ES-SCLC

Indication: The FDA approved lurbinectedin (Zepzelca) paired with atezolizumab (Tecentriq) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab-based chemotherapy.¹

Supporting data: The decision was based on findings from the phase 3 IMforte trial (NCT05091567), which demonstrated significant improvements in both progression-free survival (PFS) and overall survival (OS) with lurbinectedin plus atezolizumab (n = 242) vs atezolizumab alone (n = 241). The median PFS by independent review was 5.4 months vs 2.1 months, respectively (HR, 0.54; 95% CI, 0.43-0.67; P < .0001). The median OS was 13.2 months vs 10.6 months, respectively (HR, 0.73; 95% CI, 0.57-0.95; P = .0174).

Clinical significance: IMforte establishes the first effective maintenance therapy beyond immunotherapy alone for ES-SCLC, demonstrating meaningful PFS and OS gains in a population with historically limited post-induction options. The combination offers a new standard for eligible patients with good performance status and adequate hematologic function following first-line chemoimmunotherapy.

“The study of lurbinectedin in combination with atezolizumab vs atezolizumab alone is a practice-changing study,” Joshua K. Sabari, MD, of NYU Grossman School of Medicine and Perlmutter Cancer Center, said in an interview with OncLive®.² “It’s important to select patients who are fit, have a good performance status, and whose hematologic parameters meet the utilization [criteria for] lurbinectedin and atezolizumab, but it is something I will be using in my clinical practice. Patients who are not eligible for maintenance trials should be offered lurbinectedin plus atezolizumab in the maintenance setting for ES-SCLC.”

OTHER RELATED COVERAGE

• In a recent episode of OncLive On Air, Anne Chiang, MD, PhD, of Yale School of Medicine, and Stephen Liu, MD, of Georgetown Lombardi Comprehensive Cancer Center, discussed the significance of this approval, key efficacy and safety data from IMforte, and how the addition of this regimen in the ES-SCLC treatment paradigm may affect clinical practice.
• In a prior interview, Eric K. Singhi, MD, of The University of Texas MD Anderson Cancer Center, explained the rationale for examining the combination in this population.
• In a recent Rapid Readout, Hossein Borghaei, DO, MS, of Fox Chase Cancer Center, walked through the primary results of the IMforte trial.
• Topline findings from IMforte were shared in October 2024. At the time, Luis Paz-Ares, MD, PhD, of Hospital 12 de Octubre, stated: “These trial results demonstrate the efficacy of lurbinectedin, the most widely used agent in second-line SCLC in the US, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease.”

10/8: Cemiplimab Approved as First Adjuvant Immunotherapy in High-Risk CSCC

Indication: The FDA cleared cemiplimab-rwlc (Libtayo) for use as adjuvant treatment in adult patients with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.³

Supporting data: The approval was based on findings from the phase 3 C-POST trial (NCT03969004), which showed that adjuvant cemiplimab significantly improved disease-free survival (DFS) vs placebo. The median DFS was not reached (95% CI, not evaluable [NE]-NE) with cemiplimab vs 49.4 months (95% CI, 48.5-NE) with placebo (HR, 0.32; 95% CI, 0.20–0.51; P < .0001). Disease recurrence occurred in 9% of patients in the cemiplimab arm vs 30% in the placebo arm, including 4.8% vs 13% with distant recurrence and 3.8% vs 17% with locoregional recurrence, respectively.

Clinical significance: Cemiplimab represents the first and only immunotherapy approved in the adjuvant setting for high-risk CSCC, marking a practice-changing advance for patients with limited preventive options following curative-intent treatment. These data establish adjuvant PD-1 blockade as a new standard for reducing recurrence risk in those with high-risk CSCC after surgery and radiation.

“The approval of cemiplimab for adults with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation represents a major advance for our patients and for the field,” Vishal A. Patel, MD, FAAD, FACMS, of GW School of Medicine & Health Sciences and GW Cancer Center, said in an interview with OncLive.⁴ “Until now, these patients, often with large nodal disease, extracapsular extension, perineural invasion that's clinically or radiographically significant, or deeply invasive tumors that go down to the bone, had no real proven systemic adjuvant option. And even after surgery and radiation, the recurrence risk remained substantial, [which] created a real unmet need.”

OTHER RELATED COVERAGE

• In the full interview, Patel further discussed the clinical relevance of this approval, spotlighted key details about the pivotal phase 3 C-POST trial, and shed light on the safety profile of cemiplimab in patients with CSCC. Listen to the OncLive On Air episode, or read the Q&A.
• Data from an analysis of C-POST that was presented at the 2025 ESMO Congress showed that adjuvant treatment with cemiplimab was linked with a similar incidence of second primary tumors vs placebo in patients with high-risk CSCC after surgery and postoperative radiotherapy.
• In October 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the approval of adjuvant cemiplimab in this population.
• In a prior interview, Danny Rischin, MD, of Peter MacCallum Cancer Centre, discussed the safety and efficacy of adjuvant cemiplimab from C-POST.

10/23: Belantamab Mafodotin Plus Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Indication: The FDA approved belantamab mafodotin-blmf (Blenrep) plus bortezomib (Velcade) and dexamethasone (BVd) for use in adult patients with relapsed or refractory multiple myeloma who have previously received at least 2 lines of therapy, including a proteasome inhibitor and an immunomodulatory drug.⁵

Supporting data: Data from the phase 3 DREAMM-7 trial (NCT04246047) showed that BVd significantly improved OS and PFS vs daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd). Among patients with at least 2 prior lines of therapy, BVd (n = 108) reduced the risk of death by 51%, with a median OS of not reached vs 35.7 months with DVd (n = 109; HR, 0.49; 95% CI, 0.32-0.76). The median PFS was 31.3 months vs 10.4 months, respectively (HR, 0.31; 95% CI, 0.21-0.47). The safety profile was consistent with known toxicities, although ocular adverse effects like keratopathy and visual disturbances remained prominent.

Clinical significance: “With the approval of [belantamab mafodotin], we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following 2 or more prior lines of treatment, where options are limited,” Sagar Lonial, MD, of Winship Cancer Institute of Emory University, stated in a news release. “This approval marks an important advance in the US relapsed/refractory treatment landscape.”

OTHER RELATED COVERAGE

• This approval follows a divided recommendation from the FDA’s Oncologic Drugs Advisory Committee, which voted 5 to 3 against the risk–benefit profile of the BVd regimen. Safety concerns raised by the committee included the high incidence of ocular toxicity, the rates of serious and grade 3 or higher adverse effects, and the overall tolerability of the combination.
• In July 2025, the European Commission and Health Canada cleared BVd for use in adult patients with relapsed or refractory multiple myeloma who have previously received at least 1 therapy.
• Data from a post-hoc analysis shared during the 22nd Annual International Myeloma Society Meeting and Exposition showed that BVd led to superior PFS, sustained OS benefit, and favorable minimal residual disease negativity rates vs DVd in patients with multiple myeloma who were refractory to lenalidomide at first relapse.
• In a recent Peer Exchange, panelists Luciano J. Costa, MD, PhD, Jing Christine Ye, MD, MSc, Samer Al Hadidi, MD, MS, and Binod Dhakal, MD, discussed how data from the DREAMM-7 and DREAMM-8 studies validate the early integration of BCMA-targeted therapies like belantamab mafodotin, showing promising efficacy and manageable ocular toxicities.
• The panelists also unpacked how belantamab mafodotin shows added benefit in high-risk cytogenetic subgroups and may provide a more accessible BCMA-targeting option for community practices, although questions remain about optimal sequencing and impact on future therapies.

10/24: Revumenib in Relapsed or Refractory NPM1-Mutant AML

Indication: The FDA cleared revumenib (Revuforj) for the treatment of adult and pediatric patients at least 1 year of age with relapsed or refractory acute myeloid leukemia (AML) harboring a susceptible NPM1 mutation who lack satisfactory alternative therapeutic options.⁶

Supporting data: The decision was supported by findings from the phase 1/2 AUGMENT-101 trial (NCT04065399), in which revumenib (n = 65) elicited a complete response (CR) or CR with partial hematologic recovery (CRh) rate of 23.1% (95% CI, 13.5%-35.2%), with a median duration of response of 4.5 months (95% CI, 1.2-8.1). The median time to response was 2.8 months. Safety data were consistent with what has previously been reported, with key warnings for differentiation syndrome, QTc prolongation, and embryo-fetal toxicity.

Clinical significance: Revumenib is the first menin inhibitor approved for NPM1-mutated AML, expanding targeted therapy options for a population with limited effective treatments and high relapse risk.

“The expanded FDA approval of [revumenib] marks a major advancement in the management of acute leukemia patients. For the first time, a targeted, oral therapy that is well tolerated and efficacious is approved for R/R NPM1-mutated AML and R/R KMT2A-translocated acute leukemia,” Joshua F. Zeidner, MD, of the University of North Carolina, Lineberger Comprehensive Cancer Center, stated in a news release. “The compelling clinical activity observed with [revumenib] in clinical trials and clinical practice paves the way for a new standard of care for these two aggressive and difficult-to-treat blood cancers.”

OTHER RELATED COVERAGE

• In September 2025, the National Comprehensive Cancer Network updated its Clinical Practice Guidelines in Oncology for AML to include revumenib as a category 2A recommendation for use in patients with relapsed or refractory AML harboring an NPM1 mutation.
• In a previous interview, Eytan M. Stein, MD, of Memorial Sloan Kettering Cancer Center, and Naval G. Daver, MD, of The University of Texas MD Anderson Cancer Center, discussed the prevalence and clinical significance of NPM1 mutations and NUP98 rearrangements in AML, the efficacy and evolving role of menin inhibitors like revumenib in these genetically defined subgroups in the relapsed/refractory setting, and more.
• In a previous interview, Eunice Wang, MD, of Roswell Park Comprehensive Cancer Center, discussed the role of menin inhibitors like revumenib in AML with KM2TA rearrangements or NPM1 mutations.

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References

1. FDA approves lurbinectedin in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs for extensive-stage small cell lung cancer. FDA. October 2, 2025. Accessed October 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lurbinectedin-combination-atezolizumab-or-atezolizumab-and-hyaluronidase-tqjs-extensive
2. Sabari JK. Dr Sabari on the FDA approval of maintenance lurbinectedin plus atezolizumab for ES-SCLC. OncLive.com. October 2, 2025. Accessed October 30, 2025. https://www.onclive.com/view/dr-sabari-on-the-fda-approval-of-maintenance-lurbinectedin-plus-atezolizumab-for-es-sclc
3. FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma. FDA. October 8, 2025. Accessed October 30, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma
4. Patel VA. Dr Patel on the FDA approval of adjuvant cemiplimab for high-risk cutaneous squamous cell carcinoma. OncLive.com. October 16, 2025. Accessed October 30, 2025. https://www.onclive.com/view/dr-patel-on-the-fda-approval-of-adjuvant-cemiplimab-for-high-rish-cutaneous-squamous-cell-carcinoma
5. Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. News release. GSK. October 23, 2025. Accessed October 30, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/
6. FDA approves revumenib for relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation. FDA. October 24, 2025. Accessed October 30, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-revumenib-relapsed-or-refractory-acute-myeloid-leukemia-susceptible-npm1-mutation