This section highlights FDA-related milestones and regulatory updates for drugs developed by Seagen (SGEN).
Over the past two years, Seagen has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TUKYSA, ADCETRIS, and KEYNOTE-A39. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
TUKYSA (Tucatinib) FDA Regulatory Events
TUKYSA (Tucatinib) is a drug developed by Seagen for the following indication: Metastatic HER2-Positive Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TUKYSA (Tucatinib)
- Announced Date:
- December 10, 2025
- Indication:
- Metastatic HER2-Positive Breast Cancer
Announcement
Pfizer Inc. announced detailed results from the Phase 3 HER2CLIMB-05 trial of the tyrosine kinase inhibitor TUKYSA® (tucatinib) as part of an investigational first-line maintenance treatment combination, following chemotherapy-based induction, in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).
AI Summary
Pfizer reported detailed results from the Phase 3 HER2CLIMB-05 trial testing TUKYSA® (tucatinib) added to trastuzumab and pertuzumab as an investigational first-line maintenance therapy after chemotherapy induction in patients with HER2‑positive metastatic breast cancer. The primary analysis showed a 35.9% reduction in risk of disease progression or death versus trastuzumab and pertuzumab alone (HR 0.641; 95% CI 0.514–0.799; p<0.0001). Median progression‑free survival was 24.9 months with TUKYSA versus 16.3 months with placebo, an 8.6‑month improvement. Benefit was seen across prespecified subgroups, including patients with or without brain metastases. Overall survival data were not yet mature but trended in favor of TUKYSA.
The randomized, double‑blind trial enrolled patients who finished induction treatment with trastuzumab, pertuzumab, and a taxane and then received either TUKYSA (n=326) or placebo (n=328) with the antibody combination. The TUKYSA arm showed a generally manageable safety profile, with common adverse events including diarrhea, liver‑related events, and nausea; higher rates of asymptomatic Grade ≥3 liver enzyme elevations were typically handled with dose adjustments.
Read Announcement- Drug:
- TUKYSA (Tucatinib)
- Announced Date:
- October 14, 2025
- Indication:
- Metastatic HER2-Positive Breast Cancer
Announcement
Pfizer Inc. announced positive topline results from the Phase 3 HER2CLIMB-05 trial of first-line combination therapy with the tyrosine kinase inhibitor TUKYSA® (tucatinib) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).
AI Summary
Pfizer Inc. announced positive topline results from the Phase 3 HER2CLIMB-05 trial testing TUKYSA® (tucatinib) added to maintenance therapy with trastuzumab and pertuzumab for HER2-positive metastatic breast cancer. The trial met its main goal, showing a significant improvement in progression-free survival by investigator assessment. The combination was generally well tolerated, with a safety profile matching what is already known about each treatment.
Erika Hamilton, M.D., principal investigator of HER2CLIMB-05, said adding TUKYSA may further lower the risk of disease progression or death in this challenging breast cancer subtype. HER2 is overexpressed in about 15–20 percent of breast cancers and is linked to a poorer prognosis.
Johanna Bendell, M.D., Chief Development Officer at Pfizer Oncology, noted these results support a potential chemotherapy-free maintenance option in the first-line setting. Pfizer plans to present the HER2CLIMB-05 findings at an upcoming medical congress and discuss them with regulatory authorities.
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ADCETRIS FDA Regulatory Events
ADCETRIS is a drug developed by Seagen for the following indication: Prescription medicine directed against the CD30 protein.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADCETRIS
- Announced Date:
- February 12, 2025
- Indication:
- Prescription medicine directed against the CD30 protein
Announcement
Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.
AI Summary
Pfizer Inc. announced that the FDA has approved a supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) combined with lenalidomide and a rituximab product. This new approval is for treating adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL from indolent lymphoma, or high-grade B-cell lymphoma. The treatment is recommended for patients who have received at least two prior lines of systemic therapy and who are not eligible for autologous hematopoietic stem cell transplantation or CAR T-cell therapy. The decision was based on positive results from the Phase 3 ECHELON-3 trial, which showed a 37% reduction in the risk of death compared to a control group. This approval provides physicians with a new therapeutic option beyond traditional chemotherapy and CAR-T therapies.
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KEYNOTE-A39 FDA Regulatory Events
KEYNOTE-A39 is a drug developed by Seagen for the following indication: For the treatment of metastatic urothelial cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-A39
- Announced Date:
- August 22, 2024
- Indication:
- For the treatment of metastatic urothelial cancer
Announcement
Merck announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with enfortumab vedotin, an antibody-drug conjugate, for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (mUC) with no prior systemic therapy for mUC. T
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab) in combination with enfortumab vedotin for adult patients with unresectable locally advanced or metastatic urothelial cancer who have not received prior systemic therapy. This decision follows promising results from the Phase 3 KEYNOTE-A39 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-based chemotherapy.
The trial results suggest that the new combination can provide better treatment outcomes for patients with advanced bladder cancer. Health Canada’s approval offers an important new therapeutic option, potentially helping to improve survival rates and quality of life for those affected by this aggressive form of cancer.
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