Ibrance(palbociclib)
Oncology· 3515 cited findings· 5 source documents
Company: Pfizer Inc. →
What the regulatory reviews say
Ibrance (palbociclib) is a drug sponsored by Pfizer, Inc. It received an approval date on March 31, 2017, with a Supplemental New Drug Application (sNDA) approved on April 4, 2019.
In a multicenter, randomized, double-blind, placebo-controlled, Phase 3 trial (PALOMA-3), Ibrance plus fulvestrant demonstrated a median progression-free survival of 9.5 months (95% CI: 9.2, 11.0), compared to 4.6 months (95% CI: 3.5, 5.6) for placebo plus fulvestrant. The hazard ratio for progression-free survival was 0.461 (95% CI: 0.360, 0.591), with a p-value < 0.0001. The objective response rate for Ibrance plus fulvestrant was 24.6% (95% CI: 19.6, 30.2), versus 10.9% (95% CI: 6.2, 17.3) for placebo plus fulvestrant.
Common adverse reactions included nausea (35% all grades). Febrile neutropenia incidence was 2.5%. Permanent discontinuation due to adverse reactions occurred in 9.7% of patients.
Key figures — cited to the source page
| Median progression-free survival (IBRANCE plus Letrozole) | 24.8 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.25 |
| Median progression-free survival (Placebo plus Letrozole) | 14.5 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.25 |
| Hazard ratio for progression-free survival | 0.576 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.25 |
| Median progression-free survival (IBRANCE plus Fulvestrant) | 9.5 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.27 |
| Median progression-free survival (Placebo plus Fulvestrant) | 4.6 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.27 |
| Hazard ratio (95% CI) and p-value for PFS | 0.461 (0.360, 0.591), p < 0.0001 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.27 |
| Nausea (all grades) | 35 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.16 |
| Approval Date | March 31, 2017 | PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019), p.1 |
Source documents
- PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019) (2019)
- PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2019) (2019)
- PFIZER — Ibrance FDA Review (NDA/BLA 207103, 2018) (2018)
- Pfizer Inc. — Ibrance EMA EPAR public assessment report (EMEA/H/C/003853, 2016) (2016)
- PFIZER — Ibrance FDA Summary Review (NDA/BLA 207103, 2015) (2015)
Compared with
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.