Mississauga, Canada - ADVANZ PHARMA, a specialty pharmaceutical company with a strategic focus on complex medicines, has today announced the approval of MYTOLAC® (lanreotide) in Canada, the first generic lanreotide for the treatment of acromegaly, grade 1 and a subset of grade 2 enteropancreatic neuroendocrine tumours and carcinoid syndrome1. MYTOLAC® was approved by Health Canada on February 28, 2025.
Acromegaly is a rare disease caused by excessive Growth Hormone (GH) secretion. It is usually diagnosed in adults aged 30 to 50, although it can affect people at any age, and is characterised by quick tissue and bone growth, as well as a wide range of other symptoms2. Neuroendocrine tumours (NETs) are rare tumours that can appear anywhere in the neuroendocrine system, the system that controls hormones3. Enteropancreatic-NETs begin to grow in the stomach, intestines, appendix, or the pancreas.
Brian Canestraro, Vice President and General Manager, Canada, said “The launch of MYTOLAC in Canada represents a significant opportunity to play a role in generating health-system savings while maintaining our commitment to patient care. As ADVANZ PHARMA Canada Inc. introduces this important therapy to the Canadian market, we will leverage our comprehensive patient support programming, and broader organizational capabilities to ensure continuity of support for patients prescribed lanreotide. Our established infrastructure and heritage in innovative rare disease will enable us to deliver this cost-effective solution without compromising on the quality of care that patients deserve.”
About MYTOLAC® (lanreotide)
MYTOLAC® [lanreotide (as lanreotide acetate) injection] is indicated for:
- 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.
- The treatment of enteropancreatic neuroendocrine tumours 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.
MYTOLAC® is provided in a sterile, pre-filled syringe, co-packaged with a single use needle fitted with a shield which automatically covers and locks around the needle following administration of the product, to help prevent needle stick injury after use. MYTOLAC® is for immediate and single use following first opening. No reconstitution is required.
About ADVANZ PHARMA
Partner of choice in specialty, hospital, and rare disease medicines
ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.
For more information, please visit our Website or LinkedIn.
For media inquiries, please contact:
Courtney Baines
ADVANZ PHARMA
Tel: +44 7776 516979 Email: courtney.baines@advanzpharma.com
References
1. MYTOLAC® Product Monograph. ADVANZ PHARMA Canada Inc. 28 Feb 2025.
2. NHS. Acromegaly. Available at: https://www.nhs.uk/conditions/.... Last accessed March 2025.
3. Canadian Cancer Society. What are neuroendocrine tumours? Available at: https://cancer.ca/en/cancer-information/cancer-types/neuroendocrine-tumours/what-are-neuroendocrine-tumours. Last accessed March 2025.
