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Palbociclib + endocrine therapy (palbociclib-endocrine-therapy)
Palbociclib + endocrine therapy (generic name: palbociclib-endocrine-therapy) is a Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + drug developed by Pfizer Inc.. It is currently in preclinical development.
Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib +
Palbociclib is a small molecule used in combination with endocrine therapy, such as tamoxifen or aromatase inhibitors, to treat hormone receptor-positive breast cancer. This combination is studied in various clinical trials, including those for early-stage, advanced, and hormone receptor-positive breast cancer.
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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-endocrine-therapy |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Palbociclib works by inhibiting two proteins called CDK4 and CDK6, which act as molecular "keys" that allow breast cancer cells to progress through their growth cycle. By blocking these proteins, palbociclib essentially puts the brakes on cell division, trapping cancer cells in a resting phase where they cannot multiply. This gives the endocrine therapy (hormone-blocking drugs like tamoxifen or aromatase inhibitors) more time to work against the cancer. Endocrine therapy targets the estrogen receptor on hormone-responsive breast cancer cells, either by blocking estrogen production or by preventing estrogen from attaching to cancer cells. While endocrine therapy alone can slow cancer growth, many tumors eventually develop resistance. By combining it with palbociclib, which attacks a different part of the cancer cell's growth machinery, the two drugs work synergistically—they tackle cancer growth from multiple angles simultaneously. This combination approach has proven particularly effective in advanced breast cancer that has spread beyond the breast, where it extends the time before the cancer progresses and improves overall survival compared to endocrine therapy alone. The dual mechanism helps overcome some of the resistance mechanisms that allow cancers to escape single-drug treatments.
Approved indications
Pipeline indications
- Breast Neoplasms — preclinical
Common side effects
Key clinical trials
- Neoadjuvant Letrozole and Palbociclib in Patients With Stage II-IIIB Breast Cancer, HR+, HER2 - (Phase 2)
- A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 (Phase 3)
- Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors (Phase 1)
- Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Withou (Phase 2)
- Palbociclib With Everolimus + Exemestane In BC (Phase 1/2)
- A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aro (N/A)
- A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Adv (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 + endocrine therapy CI brief — competitive landscape report
- Palbociclib + endocrine therapy updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Palbociclib + endocrine therapy
What is Palbociclib + endocrine therapy?
How does Palbociclib + endocrine therapy work?
Who makes Palbociclib + endocrine therapy?
What is the generic name of Palbociclib + endocrine therapy?
What drug class is Palbociclib + endocrine therapy in?
What development phase is Palbociclib + endocrine therapy in?
Related
- Drug class: All Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing