MYTOLAC® is the first generic
containing lanreotide indicated in the treatment of acromegaly, enteropancreatic-NETs
and carcinoid syndrome1*
PrMYTOLAC® [lanreotide (as acetate) injection]
is indicated for:
The treatment of enteropancreatic neuroendocrine tumours (NETs) in
adult patients with Grade 1 or a subset of Grade 2 (equivalent to Ki67
<10%) unresectable, locally advanced or metastatic disease, to
delay progression. The effectiveness of lanreotide is based on a phase
III placebo-controlled study which demonstrated a benefit in
progression-free survival in patients classified with stable disease
by RECIST criteria (<20% growth) over 12 to 24 weeks. There was no
evidence of an overall survival benefit. Data on hindgut tumours were
limited.
The treatment of adult patients with carcinoid syndrome; when used,
MYTOLAC® reduces the administration frequency of short-acting
somatostatin analog rescue therapy.
The long-term treatment of adult patients with acromegaly due to
pituitary tumours who have had an inadequate response to or cannot be
treated with surgery and/or radiotherapy.
The relief of symptoms associated with acromegaly. The goal of
treatment in acromegaly is to reduce growth hormone (GH) and age
adjusted insulin-like growth factor 1 (IGF-1) levels, and where
possible, to achieve normalization of their values.
*Clinical significance of “the first generic containing lanreotide”
has not been established.
RECIST: Response Evaluation Criteria in Solid Tumours