Every FDA Oncology Approval From November 2025

In November 2025, the U.S. Food and Drug Administration (FDA) issued several approvals across oncology and supportive care. These decisions expanded treatment access for patients with breast cancer, lung cancer, leukemia, lymphoma, bladder cancer, gastric cancer and more. The following overview summarizes each approval.

FDA Approves Stoboclo and Osenvelt as Interchangeable Biosimilars

The FDA approved two biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), as interchangeable options for all approved indications of Prolia and XGEVA. Biosimilars are lower-cost, highly similar versions of biologic medicines that must meet strict FDA standards to ensure safety and effectiveness.

These medications address conditions involving bone loss, including osteoporosis in postmenopausal women and men at high fracture risk, bone loss caused by glucocorticoid treatment and bone loss in women receiving aromatase inhibitors for breast cancer. Both approvals allow pharmacy substitution for the original medicines depending on state regulations, which may increase access and reduce financial burden.

FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma

Darzalex Faspro (daratumumab and hyaluronidase-fihj) received approval for adults with high-risk smoldering multiple myeloma. This is a precancerous condition that carries a higher likelihood of progressing to active multiple myeloma.

The approval was supported by data from the AQUILA study, which compared the treatment with active monitoring in 390 patients. Median progression-free survival was not reached for patients who received Darzalex Faspro and was 41.5 months for those in the monitoring group. The prescribing information includes important safety considerations such as infection risks and blood count changes.

FDA Approves Komzifti for Relapsed or Refractory NPM1-Mutant AML

Komzifti (ziftomenib), a menin inhibitor, gained approval for adults with relapsed or refractory acute myeloid leukemia (AML) driven by an NPM1 mutation and lacking alternative treatment options. The KO-MEN-001 study evaluated 112 patients and demonstrated a complete remission (CR) plus CR with partial hematologic recovery (CRh) rate of 21.4% with a median response duration of approximately five months.

Additionally, some patients experienced improvements in transfusion dependence.

FDA Approves Poherdy as the First Interchangeable Biosimilar to Perjeta

Poherdy (pertuzumab-dpzb) received FDA approval as the first interchangeable biosimilar to Perjeta for HER2-positive breast cancer. The treatment is indicated for metastatic disease in combination with Herceptin (trastuzumab) and docetaxel, neoadjuvant therapy for tumors greater than 2 centimeters or node-positive disease and adjuvant therapy for early-stage disease at high risk of recurrence.

As an interchangeable biosimilar, Poherdy is expected to increase access to HER2-targeted therapy and potentially reduce treatment costs.

FDA Approves Epkinly Combination and Grants Full Approval for Epkinly Monotherapy in Follicular Lymphoma

The FDA approved Epkinly (epcoritamab-bysp) with Revlimid (lenalidomide) and Rituxan (rituximab) for relapsed or refractory follicular lymphoma (FL). The agency also granted traditional approval for Epkinly monotherapy after at least two prior systemic therapies.

In the EPCORE FL-1 trial of 488 patients, the combination improved progression-free survival and achieved an 89% overall response rate compared with 74% in the control arm. These results reinforce the role of Epkinly in managing previously treated FL.

FDA Grants Traditional Approval to Imdelltra for Extensive-Stage Small Cell Lung Cancer

Imdelltra (tarlatamab-dlle) earned traditional approval for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum-based chemotherapy. In the DeLLphi-304 trial, patients who received Imdelltra achieved a median overall survival of 13.6 months compared with 8.3 months for those who received standard chemotherapy. Median progression-free survival was also longer with Imdelltra.

Improvements in shortness of breath were noted at week 18, offering an additional clinical benefit for patients.

FDA Approves Hyrnuo for HER2-Mutant Advanced NSCLC

Hyrnuo (sevabertinib) received approval for adults with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain activating mutations. Patients must have previously received systemic therapy and have their mutation identified through an FDA-approved test. The SOHO-01 trial measured confirmed objective response rate and duration of response, supporting the approval.

The agency also approved the Oncomine Dx Target Test as a companion diagnostic to help identify eligible patients.

FDA Approves Keytruda or Keytruda Qlex With Padcev for Muscle Invasive Bladder Cancer

The FDA approved Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) with Padcev (enfortumab vedotin-ejfv)as neoadjuvant therapy followed by adjuvant therapy after cystectomy for cisplatin-ineligible adults with muscle invasive bladder cancer.

In the KEYNOTE-905/EV-303 study, median event-free survival and overall survival were not reached in the combination arm, compared with 15.7 months and 41.7 months, respectively, in the surgery-alone group. The safety profile was consistent with previously known side effects of each medication.

FDA Approves Imfinzi Plus FLOT for Resectable Gastric and GEJ Adenocarcinoma

Imfinzi (durvalumab) plus FLOT (fluorouracil, leucovorin, oxaliplatin and docetaxel) received approvalas presurgical and postsurgical treatment for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). Single-agent Imfinzi follows this combination.

The MATTERHORN trial enrolled 948 patients and demonstrated that median event-free survival was not reached for the Imfinzi arm and was 32.8 months for the placebo arm. The pathologic complete response rate was 19.2% with Imfinzi and FLOT compared with 7.2% with placebo and FLOT.

References

1. “FDA Approves Stoboclo and Osenvelt as Biosimilars for Some Cancers,” by Spencer Feldman. CURE; Nov. 3, 2025. https://www.curetoday.com/view/fda-approves-stoboclo-and-osenvelt-as-biosimilars-for-some-cancers
2. “FDA Approves Darzalex Faspro in High-Risk Smoldering Multiple Myeloma,” by Alex Biese. CURE; Nov. 6, 2025. https://www.curetoday.com/view/fda-approves-darzalex-faspro-in-high-risk-smoldering-multiple-myeloma
3. “FDA Approves Komzifti for NPM1-Mutant Acute Myeloid Leukemia,” by Alex Biese. CURE; Nov. 13, 2025. https://www.curetoday.com/view/fda-approves-komzifti-for-npm1-mutant-acute-myeloid-leukemia
4. “FDA Approves First Interchangeable Biosimilar to Perjeta in HER2+ Breast Cancer,” by Ryan Scott. CURE; Nov. 13, 2025. https://www.curetoday.com/view/fda-approves-first-interchangeable-biosimilar-to-perjeta-in-her2-breast-cancer
5. “FDA Approves Epkinly Combo in Relapsed/Refractory Follicular Lymphoma,” by Alex Biese. CURE; Nov. 18, 2025. https://www.curetoday.com/view/fda-approves-epkinly-combo-in-relapsed-refractory-follicular-lymphoma
6. “FDA Approves Imdelltra for Extensive-Stage Small Cell Lung Cancer,” by Spencer Feldman. CURE; Nov. 19, 2025. https://www.curetoday.com/view/fda-approves-imdelltra-for-extensive-stage-small-cell-lung-cancer
7. “FDA Approves Hyrnuo in Some with Locally Advanced/Metastatic NSCLC,” by Ryan Scott. CURE; Nov. 19, 2025. https://www.curetoday.com/view/fda-approves-hyrnuo-in-some-with-locally-advanced-metastatic-nsclc
8. “FDA Approves Keytruda and Padcev for Muscle Invasive Bladder Cancer,” by Spencer Feldman. CURE; Nov. 21, 2025. https://www.curetoday.com/view/fda-approves-keytruda-and-padcev-for-muscle-invasive-bladder-cancer
9. “FDA Approves Keytruda and Padcev for Muscle Invasive Bladder Cancer,” by Spencer Feldman. CURE; Nov. 21, 2025. https://www.curetoday.com/view/fda-approves-keytruda-and-padcev-for-muscle-invasive-bladder-cancer

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