Bristol-Myers Squibb Company — Yervoy EMA EPAR public assessment report (EMEA/H/C/002213, 2011)
Bristol-Myers Squibb Company · 2011 · EMA EPAR public assessment report · company profile →
Report summary
This report summarizes the 2011 EMA assessment of Bristol-Myers Squibb's Yervoy (ipilimumab) for advanced melanoma in previously treated adults, leading to marketing authorization. The submission detailed satisfactory manufacturing, a 36-month shelf life, and non-clinical studies supporting its mechanism and anti-tumor activity. Clinical pharmacology showed dose-proportional exposure, a 10-17 day half-life, and no significant impact of age, gender, or organ function on clearance. Pivotal Phase 3 and Phase 2 trials demonstrated efficacy, despite common immune-related adverse events (irAEs) like gastrointestinal and skin reactions. The CHMP concluded a positive benefit-risk balance for the 3 mg/kg dose, citing a clinically relevant overall survival benefit outweighing irAEs, while recommending further post-marketing studies on specific patient populations and dose comparisons.
Key findings — cited to the page
| Ipilimumab injection pH | 7.0 | Ipilimumab · p.12 |
| Bioburden limit before final sterile filtration | 10 cfu/100 mL | · p.13 |
| Shelf life of ipilimumab concentrate for solution for infusion | 36 months | Ipilimumab · p.9 |
| Ipilimumab injection concentration | 5 mg/mL | Ipilimumab · p.12 |
| Shelf life of ipilimumab drug substance | 36 months | Ipilimumab · p.9 |
| Proposed target population for Yervoy | patients with a diagnosis of unresectable stage III or IV melanoma who, in response to at least 1 cycle first-line therapy, have relapsed following an objective response, failed to demonstrate an objective response, or could not tolerate IL-2, dacarbazine and/or temozolomide therapy due to unacceptable toxicity | Yervoy (ipilimumab) · p.8 |
| Application submission date | 5 May 2010 | Yervoy (ipilimumab) · EU · p.6 |
| Marketing Authorisation granted date | 25 March 2011 | Yervoy (ipilimumab) · United States · p.6 |
| Indication applied for | treatment of advanced melanoma in adults who have received prior therapy | Yervoy (ipilimumab) · EU · p.6 |
| Predicted molecular weight of Ipilimumab | 147,991 Daltons | Ipilimumab · p.9 |
| CHMP positive opinion date | 19 May 2011 | Yervoy (ipilimumab) · EU · p.7 |
| treatment-related AEs leading to discontinuation | 6.8 % | MDX010-20 · p.69 |
Source: Bristol-Myers Squibb Company ↗ · 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 →