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Palbociclib + aromatase inhibitor (palbociclib-aromatase-inhibitor)
Palbociclib + aromatase inhibitor (generic name: palbociclib-aromatase-inhibitor) is a Palbociclib + aromatase inhibitor Small molecule drug developed by Pfizer Inc.. It is currently in preclinical development.
Palbociclib + aromatase inhibitor
Palbociclib combined with an aromatase inhibitor is a CDK4/6 inhibitor plus hormone therapy used for hormone receptor-positive, HER2-negative advanced breast cancer. Palbociclib blocks cell cycle progression while the aromatase inhibitor reduces estrogen production, providing complementary mechanisms to slow cancer growth. This combination significantly improves progression-free survival compared to hormone therapy alone.
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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-aromatase-inhibitor |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Palbociclib + aromatase inhibitor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Cancer cells grow by moving through distinct phases of the cell cycle, controlled by proteins called CDK4 and CDK6. Palbociclib works by blocking these proteins, essentially putting cancer cells in a holding pattern and preventing them from progressing to the next division phase. This slows or stops the cancer's ability to multiply. Aromatase inhibitors work by a different mechanism—they reduce the body's estrogen production. Many breast cancers depend on estrogen to grow, so lowering estrogen starves these cancer cells of a critical growth signal. By using both drugs together, they attack the cancer from two angles: stopping cell division directly while also removing one of the main fuels that drives growth. This combination is particularly effective in hormone receptor-positive, HER2-negative breast cancers, which have receptors on their surface that respond to estrogen. The pairing of a direct cell-cycle inhibitor with hormone suppression has proven more effective than either approach alone, helping delay disease progression and improve outcomes for patients with advanced breast cancer.
Approved indications
Pipeline indications
- Metastatic Breast Cancer — preclinical
Common side effects
Key clinical trials
- 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)
- A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aro (N/A)
- Palbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer (Phase 3)
- Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive (Phase 2)
- A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment W (Phase 2)
- Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone- (Phase 2)
- WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to (Phase 1)
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 + aromatase inhibitor CI brief — competitive landscape report
- Palbociclib + aromatase inhibitor updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Palbociclib + aromatase inhibitor
What is Palbociclib + aromatase inhibitor?
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Related
- Drug class: All Palbociclib + aromatase inhibitor drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing