Pfizer Inc. — Ibrance EMA EPAR public assessment report (EMEA/H/C/003853, 2016)
Pfizer Inc. · 2016 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Pfizer's Ibrance (palbociclib) in combination with endocrine therapy for HR-positive, HER2-negative advanced/metastatic breast cancer. This decision, based on a positive CHMP opinion in September 2016, followed extensive chemical, non-clinical, and clinical development. Palbociclib, a selective CDK4/6 inhibitor, demonstrated significant anti-tumor activity. Clinical trials, including PALOMA-2 and PALOMA-3, showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) when Ibrance was combined with letrozole or fulvestrant, respectively. While efficacy was robust, myelosuppression, particularly neutropenia, was identified as a key safety concern, though generally manageable.
Key findings — cited to the page
| Grade 3/4 TEAEs (palbociclib arm, PALOMA-1) | 77.1 % | PALOMA-1 · p.138 |
| Grade 3/4 TEAEs (control arm, PALOMA-1) | 20.8 % | PALOMA-1 · p.138 |
| Grade 3 or 4 TEAEs (palbociclib arm, PALOMA-3) | 70.1 % | PALOMA-3 · p.138 |
| Grade 3 or 4 TEAEs (control arm, PALOMA-3) | 18.0 % | PALOMA-3 · p.138 |
| Grade 3/4 TEAEs (control arm, PALOMA-2) | 25.2 % | PALOMA-2 · p.138 |
| Grade 3/4 TEAEs (palbociclib arm, PALOMA-2) | 77.5 % | PALOMA-2 · p.138 |
| NOEC for Daphnia sp. Reproduction Test | 0.27 mg a.i./L | · p.29 |
| deaths (palbociclib + fulvestrant) | 71 (20.5%) | Study 1023 · p.67 |
| Palbociclib capsule dosage strength | 125 mg | · p.17 |
| Maximum dose of palbociclib | 125 mg | · p.18 |
| Recommended dose and schedule | 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment with food | Ibrance · p.13 |
| CHMP positive opinion date | 15 September 2016 | Ibrance · p.9 |
Source: Pfizer Inc. ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →