Last reviewed · How we verify
BGB-16673
BGB-16673 is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors, blocking estrogen-driven cancer cell growth.
BGB-16673 is a selective estrogen receptor degrader (SERD) that binds to and degrades estrogen receptors, blocking estrogen-driven cancer cell growth. Used for Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.
At a glance
| Generic name | BGB-16673 |
|---|---|
| Sponsor | BeOne Medicines |
| Drug class | Selective Estrogen Receptor Degrader (SERD) |
| Target | Estrogen Receptor (ER) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
BGB-16673 functions as a SERD by binding to the estrogen receptor with high affinity and promoting its proteasomal degradation, thereby eliminating both ligand-dependent and ligand-independent estrogen receptor signaling. This mechanism is designed to overcome resistance to selective estrogen receptor modulators (SERMs) and aromatase inhibitors in hormone receptor-positive breast cancer. By completely degrading the receptor rather than merely blocking it, SERDs provide a more comprehensive suppression of estrogen receptor-mediated proliferation.
Approved indications
- Hormone receptor-positive, HER2-negative advanced or metastatic breast cancer
Common side effects
- Hot flashes
- Nausea
- Fatigue
- Vaginal dryness
Key clinical trials
- A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors (PHASE3)
- A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies (PHASE1, PHASE2)
- A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (PHASE3)
- A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies (PHASE1, PHASE2)
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB-16673 in Adults With Chronic Spontaneous Urticaria (PHASE1)
- A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors (PHASE3)
- Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants (PHASE1)
- A Study of How [14C]-BGB-16673 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Participants (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BGB-16673 CI brief — competitive landscape report
- BGB-16673 updates RSS · CI watch RSS
- BeOne Medicines portfolio CI