Merck Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer - Seite 3

regulatory requirement to establish the safety and effectiveness of a
drug through adequate and well-controlled studies to support
approval. The orphan drug designation for M7824 applies only to BTC.

About Biliary Tract Cancer (BTC)

BTC is a collective term for a group of rare and aggressive
gastrointestinal cancers, including intrahepatic cholangiocarcinoma
(iCC), extrahepatic cholangiocarcinoma (eCC), and gallbladder
carcinoma (GBC).[1] Surgery is the only curative treatment, but most
patients present with advanced disease and therefore have a limited
survival.[1] Approximately 140,000 cases of BTC are estimated to
occur annually world-wide.[2] However, incidence of BTC varies in
different parts of the world: the incidence of cholangiocarcinomas is
rising in the Western world, with reports of up to 2 in 100,000[4].
By contrast, in Asian countries, the incidence is much higher.[4] GBC
also has an incidence of 2 in 100,000,?but is much more prevalent in
parts of South America.[4]

Collectively these cancers present late in the majority of
patients and long-term outcomes for resectable patients are poor with
median survival in the advanced setting less than 1?year.[1],[3]

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References

1. Blair A B et al. Immunotherapy as a treatment for biliary tract
cancers: A review of approaches with an eye to the future. Current
Problems in Cancer (2018) https://www.sciencedirect.com/science/ar
ticle/pii/S0147027217301083?via%3DihubAccessed November 2018
2. Global Burden of Disease Study 2013. The Lancet
2015;385(9963):117-171.
3. Hezel AF et al. Genetics of biliary tract cancers and emerging
targeted therapies. J Clin Oncol 2010;28:3531-40.
http://dx.doi.org/10.1200/JCO.2009.27.4787 Accessed November 2018
4. Goldstein D et al. New molecular and immunotherapeutic approaches
in biliary cancer. ESMO Open (2017). Published online 2017 Mar 27.
doi: https://dx.doi.org/10.1136%2Fesmoopen-2016-000152 Accessed
November 2018
5. Lamarca A, et al. Ann Oncol. 2014;25(12):2328-2338.

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