Adlumiz is the first and only product approved in Japan for cancer cachexia. Adlumiz is brought to patients with malignancy-associated weight loss and anorexia or cancer cachexia to improve their lives with a novel anabolic, anticatabolic, appetite-stimulating and fast-acting treatment with sustained effects that fulfills the need for a standard of care in these populations. Adlumiz is approved in the following malignant tumours: non-small cell lung cancer, gastric cancer, pancreatic cancer, colorectal cancer.

Adlumiz is approved in Japan only.

PMDA Approval details

How does Adlumiz work?

Ghrelin is an endogenous peptide with short half-life (approx. 30 min) secreted by the stomach in response to fasting; upon binding to its receptor, ghrelin stimulates multiple pathways in the regulation of body weight, lean body mass (LBM), appetite, and metabolism1,2. Elevated ghrelin levels have been observed in patients with cachexia report in different types of cancer1,2. Exogenous ghrelin administration in these patients has been shown to increase appetite and energy intake, and reduce energy expenditure, thereby improving energy balance1-3. The net effect is increased LBM and fat mass preservation1,2.


Adlumiz contains the active substance anamorelin hydrochloride. Anamorelin is a novel, oral selective ghrelin receptor agonist stimulating multiple pathways involved in the regulation of appetite, body weight, LBM, and metabolism, thereby rapidly promoting restoration of energy balance in patients with cancer and malignancy-associated weight loss and anorexia4-10. Anamorelin has shown rapid and sustained benefits in patients with various cancer types and anorexia/cachexia6-10.


Anamorelin offers advantages over parenteral ghrelin, given its oral administration and longer half-life3.


References:



  1. Guillory B, et al. Vitam Horm 2013;92:61–106.

  2. Müller TD, et al. J Cachexia Sarcopenia Muscle 2010;1:159–167.

  3. Akamizu T, Kangawa K. J Cachexia Sarcopenia Muscle 2010;1:169–176.

  4. Kumor K, Polvino W. Support Care Cancer 2006;14: abstract 03-009.

  5. Garcia JM, Polvino WJ. Oncologist 2007;12:594–600.

  6. Garcia JM, et al. Support Care Cancer 2013;21:129–137.

  7. Garcia JM, et al. Lancet Oncol 2015;16:108–116.

  8. Temel JS, et al. Lancet Oncol 2016;17:519–531.

  9. Katakami N, et al. Cancer 2018;124:606–616.

  10. Hamauchi S, et al. Cancer 2019;125:4294–4302.

More about cancer cachexia

Cancer cachexia is a multifactorial, common but often underrecognized, debilitating clinical condition1-5, shown to adversely impact patients’ tolerance and response to anticancer therapy5-9, as well as the survival of patients with advanced tumors9-14. Across all tumor types, more than 50% of patients with cancer develop cachexia, with a prevalence of up to 80% in patients with advanced cancers1; the condition has particularly high prevalence among patients with gastrointestinal (GI) and non-small cell lung cancers2. Cancer cachexia is often underrecognized, inadequately managed, and considered inevitable for patients with cancer3,4.


Weight loss and anorexia are key clinical hallmarks of cancer cachexia17 correlated with shorter survival9-14; mortality among patients with cancer cachexia is estimated at 80%, with over 30% of deaths linked to cancer cachexia1. Weight and skeletal muscle mass loss are associated with metabolic dysfunction and cannot be fully reversed by conventional nutritional support16-17.


Weight loss during cancer treatment has been associated with an increase in therapy-related toxicities5-8, negatively interfering with completion of therapy cycles15 and impairing response to cancer treatment9.


Current treatment approaches for cancer cachexia have limited success18-21, with no available options to substantially improve LBM22 and potentially counteract the metabolic impairment associated with muscle depletion.


References:



  1. von Haehling S, Anker SD. J Cachexia Sarcopenia Muscle 2010;1:1–5.

  2. Del Ferraro C, et al. J Hosp Palliat Nurs 2012;14.

  3. Benner A, et al. Support Care Cancer 2013;21(Suppl 1): abstract 0808.

  4. Muscaritoli M, et al. Ann Oncol 2016;27:2230–2236.

  5. Fukahori M, et al. Support Care Cancer 2021;29:341–348.

  6. da Rocha IMG, et al. J Cachexia Sarcopenia Muscle 2019;10:445–454.

  7. Mitsunaga S, et al. Support Care Cancer 2020;28:5271–5279.

  8. Molfino A, et al. Clin Nutr 2021; https://doi.org/10.1016/j.clnu.2021.02.016.

  9. Roch B, et al. Lung Cancer 2020;143:19–26.

  10. Gallois C, et al. Clin Res Hepatol Gastroenterol 2021;45:101603.

  11. Guercio BJ, et al. JNCI Cancer Spectr 2020;4:pkaa024.

  12. Kim KW, et al. BMC Cancer 2021;21:157.