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palbociclib plus fulvestrant (palbociclib-plus-fulvestrant)
palbociclib plus fulvestrant (generic name: palbociclib-plus-fulvestrant) is a Patients treated with the combination of palbociclib and fulvestrant drug developed by Pfizer Inc.. It is currently in preclinical development.
Patients treated with the combination of palbociclib and fulvestrant
Palbociclib, a small molecule, is used in combination with fulvestrant to treat various types of breast cancer, including metastatic, advanced, luminal, HER2-negative, and ER-positive breast cancer. The combination of palbociclib and fulvestrant has been studied in clinical trials, such as the PARSIFAL study, to evaluate its efficacy and safety in these patient populations.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | palbociclib-plus-fulvestrant |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Patients treated with the combination of palbociclib and fulvestrant |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
This combination works by attacking hormone-sensitive breast cancer on two fronts. Palbociclib is a small molecule that inhibits CDK4 and CDK6 proteins, which are essential for pushing cells through their division cycle. By blocking these proteins, palbociclib essentially puts the brakes on cell division, causing cancer cells to pause their growth. Fulvestrant takes a different approach by acting as an estrogen receptor antagonist. In hormone receptor-positive breast cancers, estrogen binds to receptors on the cancer cell surface and sends signals telling the cell to grow and divide. Fulvestrant blocks these receptors and actually causes them to degrade, eliminating the cancer cell's ability to respond to estrogen signals. Together, these two drugs create a more powerful treatment: palbociclib directly halts the cell division machinery while fulvestrant removes the hormone signal that was driving growth in the first place. This combination approach is particularly effective for advanced breast cancers that have stopped responding to hormone therapy alone, offering patients a more durable treatment response.
Approved indications
Pipeline indications
- Breast Neoplasms — preclinical
Common side effects
Key clinical trials
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metas (Phase 1/2)
- TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATIO (N/A)
- Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormo (N/A)
- Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Withou (Phase 2)
- A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking (N/A)
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Adv (Phase 3)
- Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant (Phase 3)
- Palbociclib After CDK and Endocrine Therapy (PACE) (Phase 2)
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:
- palbociclib plus fulvestrant CI brief — competitive landscape report
- palbociclib plus fulvestrant updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about palbociclib plus fulvestrant
What is palbociclib plus fulvestrant?
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Related
- Drug class: All Patients treated with the combination of palbociclib and fulvestrant drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing