Covering Every FDA Oncology Approval From October 2025

In October 2025, the U.S. Food and Drug Administration (FDA) granted approval to multiple new cancer therapies and supportive care options, covering treatments for acute myeloid leukemia (AML), multiple myeloma, breast cancer, and more.

FDA Approves Revuforj for Relapsed/Refractory NPM1-Mutant AML

The FDA has approved Revuforj (revumenib), a menin inhibitor, for the treatment of adults and children aged 1 year and older with relapsed or refractory AML who have a specific NPM1 mutation and no satisfactory alternative treatment options. This marks a significant step for patients who previously had limited therapy choices.

Approval was based on results from the AUGMENT-101 clinical trial, a multicenter, open-label study. Patients enrolled in the trial had their NPM1 mutation confirmed using genetic testing methods such as next-generation sequencing or polymerase chain reaction. The trial measured outcomes including complete remission (CR), complete remission with partial hematologic recovery (CRh), the duration of these responses, and conversion from transfusion dependence to independence.

The study found a 23.1% rate of CR or CRh, with a median response duration of 4.5 months. Among 46 patients who were dependent on red blood cell or platelet transfusions at the start of the study, eight patients (17%) became transfusion-independent during any 56-day post-treatment period. These findings highlight Revuforj as a promising option for patients with relapsed or refractory AML driven by NPM1 mutations.

FDA Approves Blenrep With Velcade and Dexamethasone for Relapsed Multiple Myeloma

The FDA has approved Blenrep (belantamab mafodotin-blmf) in combination with Velcade (bortezomib) and dexamethasone (together referred to as BVd) for adults with relapsed or refractory multiple myeloma who have received at least two prior treatment regimens, including a proteasome inhibitor and an immunomodulatory drug.

Approval was based on data from the phase 3 DREAMM-7 trial, which demonstrated that BVd therapy significantly improved patient outcomes. In patients who had received two or more prior lines of therapy, BVd reduced the risk of death by 51% and tripled median progression-free survival to 31.3 months, compared with a daratumumab-based regimen (DVd). The combination therapy was generally well tolerated, with safety profiles consistent with the known effects of each individual drug.

This approval provides a new treatment option for multiple myeloma patients who have exhausted several lines of therapy, offering both improved survival and better disease control.

FDA Approves Guardant360 Test With Inluriyo for ESR1-Mutant Breast Cancer

The FDA approved Guardant360 CDx, a blood-based companion diagnostic test, alongside Inluriyo (imlunestrant)for adults with advanced or metastatic breast cancer that harbors ESR1 mutations. Patients eligible for treatment must have experienced disease progression after at least one prior hormone therapy.

In the phase 3 EMBER-3 trial, Guardant360 CDx identified patients with ESR1 mutations who might benefit from Inluriyo. Treatment with Inluriyo led to a 38% lower risk of disease progression or death compared with standard hormone therapy. Specific ESR1 mutations, including E380, V422del, S463, L469, L536, Y537 and D538, are used to determine patient eligibility.

Guardant360 CDx is the first FDA-approved blood test for comprehensive genomic testing, now used to guide treatment in multiple cancers. It is widely covered by Medicare and private insurers, making it accessible to more than 300 million people. This approval reinforces the growing role of blood-based genomic testing in personalized cancer care.

FDA Approves Zepzelca With Tecentriq for Extensive-Stage Small Cell Lung Cancer

The FDA has approved Zepzelca (lurbinectedin) in combination with Tecentriq (atezolizumab) for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed following first-line induction therapy with Tecentriq, carboplatin, and etoposide.

In the IMforte clinical trial, 483 patients were randomized to receive either Zepzelca plus Tecentriq or Tecentriq alone. The combination therapy improved median overall survival to 13.2 months, compared with 10.6 months for Tecentriq alone. Median progression-free survival also increased to 5.4 months versus 2.1 months. Zepzelca works as an alkylating agent, killing cancer cells by damaging their DNA and stopping division.

The prescribing information includes important warnings for myelosuppression, liver toxicity, infusion-related reactions, and embryo-fetal risks, which should be carefully monitored during treatment.

FDA Approves Libtayo for High-Risk Cutaneous Squamous Cell Carcinoma

The FDA has approved Libtayo (cemiplimab-rwlc) for adjuvant treatment in adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation.

This approval was based on the C-POST trial, which included 415 patients at high risk of recurrence. Patients receiving Libtayo had median disease-free survival that was not reached, compared with 49.4 months in the placebo group, highlighting the drug’s ability to prevent recurrence.

Libtayo treatment may cause immune-mediated side effects and infusion reactions, and it is administered intravenously at 350 mg every three weeks for 12 weeks, followed by 700 mg every six weeks or 350 mg every three weeks until recurrence, unacceptable toxicity, or for up to 48 weeks.

References

1. “FDA Approves Revuforj for R/R NPM1-Mutant AML,” by Alex Biese. CURE; Oct. 24, 2025.https://www.curetoday.com/view/fda-approves-revuforj-for-rr-npm1-mutant-alm
2. “FDA Approves Blenrep Plus Velcade/Dexamethasone For R/R Multiple Myeloma,” by Alex Biese. CURE; Oct. 23, 2025. https://www.curetoday.com/view/fda-approves-blenrep-plus-velcade-dexamethasone-for-r-r-multiple-myeloma
3. “FDA Approves Guardant360 Test With Inluriyo for ESR1 Breast Cancer,” by Spencer Feldman. CURE; Oct. 2, 2025. https://www.curetoday.com/view/fda-approves-guardant360-test-with-inluriyo-for-esr1-breast-cancer
4. “FDA Approves Zepzelca Plus Tecentriq for Extensive-Stage Small Cell Lung Cancer,” by Alex Biese. CURE; Oct. 2, 2025. https://www.curetoday.com/view/fda-approves-zepzelca-plus-tecentriq-for-extensive-stage-small-cell-lung-cancer
5. “FDA Approves Libtayo for Cutaneous Squamous Cell Carcinoma Treatment,” by Alex Biese. CURE; Oct. 8, 2025. https://www.curetoday.com/view/fda-approves-libtayo-for-cutaneous-squamous-cell-carcinoma-treatment

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