palbociclib

Oncology· 31 cited findings· 1 source document

What the regulatory reviews say

Palbociclib is a drug evaluated in clinical trials involving 128 participants. Efficacy findings include a median overall survival (OS) of 13.04 months compared to 8.54 months, and 11.43 months compared to 10.68 months. The median event-free survival (EFS) was 4.4 months compared to 1.5 months, with a hazard ratio for EFS of 2.03. The hazard ratio for OS was 0.94.

Safety data indicates that the incidence of Grade 3-4 treatment-emergent adverse events (TEAEs) was 82.9% in the palbociclib arm and 81.0% in the control arm. All-causality serious adverse events (SAEs) occurred in 36.6% of the palbociclib arm and 19.0% of the control arm. Treatment-related SAEs were observed in 17.1% of the palbociclib arm and 14.3% of the control arm. Infections were reported in 14.6% of the palbociclib arm and 4.8% of the control arm, with febrile neutropenia at 9.8% in the palbociclib arm. TEAEs leading to permanent treatment discontinuation occurred in 4.9% of the palbociclib arm.

Key figures — cited to the source page

Median OS (months) - palbociclib arm	13.04	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.8
Median OS (months) - comparator arm	8.54	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.8
Median EFS (months) - palbociclib arm	4.4	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.8
Median EFS (months) - comparator arm	1.5	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.8
Incidence of TEAEs Grade 3-4 (palbociclib arm)	82.9	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.11
Incidence of TEAEs Grade 3-4 (control arm)	81.0	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.11
Incidence of all-causality SAEs (palbociclib arm)	36.6	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.11
Incidence of all-causality SAEs (control arm)	19.0	Pfizer Inc. — Ibrance EMA EPAR variation assessment report, p.11

Source documents

Pfizer Inc. — Ibrance EMA EPAR variation assessment report (EMEA/H/C/003853, 2016) (2016)

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.