Merck & Co., Inc. — Keytruda EMA EPAR public assessment report (EMEA/H/C/003820, 2015)

Merck & Co., Inc. · 2015 · EMA EPAR public assessment report · company profile →

Report summary

This EMA report details the regulatory assessment of Keytruda (pembrolizumab) for unresectable or metastatic melanoma. It covers the drug's manufacturing, quality, and non-clinical safety, noting an 18-month shelf life and dose-dependent pharmacokinetics. Clinical studies (P001, P002, P006) demonstrated Keytruda's efficacy, showing improved objective response rates, progression-free survival, and overall survival compared to chemotherapy or ipilimumab in both ipilimumab-naïve and refractory patients. The pharmacokinetics showed dose-proportional exposure and a 26-day half-life. Safety data highlighted immune-related adverse events, managed through risk minimization and educational programs. The CHMP concluded a positive benefit-risk balance, requiring post-authorization efficacy and biomarker studies.

Key findings — cited to the page

Grade 3-5 AEs	43.5 %	P001 and P002 · p.112
Grade 3-5 drug-related AEs	13.5 %	P001 and P002 · p.144
Grade 3-5 AEs	45.0 %	P001 and P002 · p.112
Grade 3-5 AEs	41.9 %	P001 and P002 · p.112
drug-related Grade 3-5 AEs	13.5 %	P001 + P002 · p.128
Grade 3-5 AEs	14 %	· p.145
Grade 3-5 AEs	26.3 %	· p.145
Grade 3-5 AEs	11.2 %	· p.145
Proposed indication	treatment of unresectable or metastatic melanoma in adults	Keytruda · p.7
PFS p-value for IPI-naïve (P001 Part D)	0.530	P001 Part D · p.102
p-value for overall survival for ipilimumab vs gp100 vaccine in previously treated melanoma	0.003	Ipilimumab (Yervoy) · p.10
Vemurafenib approval in EU	2012	Vemurafenib (Zelboraf) · EU · p.10

Source: Merck & Co., 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 →