Alimta(pemetrexed)

Oncology· 44 cited findings· 1 source document

What the regulatory reviews say

Alimta (pemetrexed) received Marketing Authorisation on 20 September 2004. A Phase III trial randomized 539 patients in a 2:1 ratio. The trial assessed efficacy and safety, with a Type II variation deemed acceptable.

Key efficacy findings include a Median Progression-Free Survival of 4.11 months, compared to 2.83 months for the placebo arm, with a Progression-Free Survival Hazard Ratio of 0.62 (p=0.00006). Median Overall Survival was 13.86 months, versus 11.10 months for the placebo arm, resulting in an Overall Survival Hazard Ratio of 0.78 (p=0.0343). The Objective Response Rate was 4.2%, compared to 1.1% for the placebo arm (p=0.067).

Safety data indicated 56 deaths during induction treatment, with 11 deaths attributed to study drug-related adverse events. Dose delays due to adverse events occurred in 20.1% of patients, and dose reductions in 3.1%. Treatment discontinuation due to serious adverse events affected 3.9% of patients.

Key figures — cited to the source page

Median Progression-Free Survival (months)	4.11	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.12
Median Progression-Free Survival (months) for placebo arm	2.83	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.12
Progression-Free Survival Hazard Ratio	0.62	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.12
Median Overall Survival (months)	13.86	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.14
Median Overall Survival (months) for placebo arm	11.10	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.14
Overall Survival Hazard Ratio	0.78	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.14
deaths due to study drug-related AEs	11	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.27
Marketing Authorisation (MA) grant date	20 September 2004	Eli Lilly and Company — Alimta EMA EPAR variation assessment, p.3

Source documents

Eli Lilly and Company — Alimta EMA EPAR variation assessment report (EMEA/H/C/000564, 2004) (2004)

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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.