studies have not been conducted to evaluate the carcinogenic or
mutagenic potential of galcanezumab. There is no evidence to suggest
that chronic treatment with galcanezumab would increase the risk of
carcinogenesis based on data from pharmacology and chronic toxicology
studies with galcanezumab, as well as an assessment of the literature
with the ICH guidance,2
carcinogenicity studies in animals were not scientifically
of Malignancy in Phase 3 Migraine Prevention Clinical Trials
the galcanezumab placebo-controlled, phase 3 migraine prevention
clinical trials, 6 cases of malignant neoplasms were reported as
serious adverse events during galcanezumab treatment (Table
of the 6 cases were considered related to galcanezumab treatment by
the investigator or by Eli Lilly and Company. Although similar events
were not reported by patients on placebo, in view of the relatively
short time interval between the start of galcanezumab treatment in
these cases and the event onset, an association with galcanezumab is
unlikely. Furthermore, the incidence of cancers of the breast,
colorectum, and cervix uteri are among the highest reported in more
developed regions globally.3
1. Migraine Prevention: Cases of Malignant Neoplasms During Phase 3
Related to Treatment by the Investigator or by Eli Lilly and
months after first dose,
24 days since last dose of GMB.
month after first dose of GMB.
month after first dose of GMB,
patient reported breast lump
was subsequently diagnosed
with tubular breast
days after fourth dose, patient reported cough which never
resolved and was subsequently diagnosed as lung cancer 42 days
after the last dose during the post-treatment phase.
120 mg / GMB 240 mga
days after starting GMB, patient reported a wound on breast nipple
that was subsequently diagnosed 9 months after beginning GMB as
/ GMB 240 mgb
days after starting GMB during open-label treatment (on the same
day as 9th dose of GMB 240 mg), patient was hospitalized for
GMB = galcanezumab; PBO = placebo.
Patient received GMB 120 mg during double-blind treatment and
GMB 240 mg during open-label treatment.
Patient received PBO during double-blind treatment and GMB 240
mg during open-label treatment.
The recommended dose is 120 mg galcanezumab injected subcutaneously
once monthly, with a 240 mg loading dose as the initial dose .1
The results of a maintenance dose of galcanezumab 240 mg once monthly
are also described here. Even though this dose has been tested in
pivotal studies, it has not been approved and therefore is not
of Analysis Set
Double-Blind, Placebo-Controlled Studies
carcinogenic potential of galcanezumab was evaluated in phase 3
randomized, double-blind, placebo-controlled studies in adult
patients for the prevention of
migraine (EVOLVE-1 and EVOLVE-2),4,5
studies had a duration of
months for prevention of episodic migraine,4,5
months for prevention of chronic migraine, with an optional 9-month
open-label extension phase.6
were randomized at the beginning of double-blind treatment in a 2:1:1
ratio to receive monthly subcutaneous injections of
120 mg with a loading dose of 240 mg, or
pooled analysis of 2886 adult patients included a total of 1435
patients that received monthly doses of galcanezumab (120 mg or
240 mg) administered subcutaneously.7
recommended dose is 120 mg galcanezumab injected subcutaneously once
monthly, with a 240 mg loading dose as the initial dose.1
Please note that the results of a maintenance dose of 240 mg
galcanezumab once monthly are also included in this response. Even
though this dose has been tested in pivotal studies, it has not been
approved and therefore is not recommended.
majority of patients were female (>80%) and Caucasian (>75%),
with a mean age of 41 to 42 years.7
has also been studied in a phase 3, open-label, 12-month safety study
for the prevention of episodic or chronic migraine.8
this study, 270 patients were randomized to receive 12 monthly
subcutaneous injections of
120 mg with a loading dose of 240 mg, or
Emgality [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands.
International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use. 2011. Preclinical
Safety Evaluation of Biotechnology-Derived Pharmaceuticals. S6(R1).
Accessed January 24, 2018.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab
for the prevention of episodic migraine: the EVOLVE-1 randomized
clinical trial. JAMA Neurol. 2018;75(9):1080-1088.
Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of
galcanezumab for the prevention of episodic migraine: results of the
EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia.
Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic
migraine: the randomized, double-blind, placebo-controlled REGAIN
study. Neurology. 2018;91(24):e2211-e2221.
Stauffer VL, Wang S, Bangs M, et al. Phase 3 safety data from
studies comparing galcanezumab and placebo in patients with episodic
and chronic migraine. Poster presented at: European Academy of
Neurology (EAN) – 4th
Congress; June 16-19, 2018; Lisbon, Portugal.
Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term,
open-label safety study of galcanezumab in patients with migraine.
BMC Neurology. 2018;18(1):188.
= calcitonin gene-related peptide
= International Conference on Harmonisation
medicinal product is subject to additional monitoring. This will
allow quick identification of new safety information. Healthcare
professionals are asked to report any suspected adverse reactions.