Napabucasin

Extended indication	Metastatic gastric or gastroesophageal adenocarcinoma in adults, 2L+, in combination with paclitaxel.
Therapeutic value	No judgement
Registration phase	Clinical trials

Product

Active substance	Napabucasin
Domain	Oncology and Hematology
Reason of inclusion	New medicine (specialité)
Main indication	Stomach cancer
Extended indication	Metastatic gastric or gastroesophageal adenocarcinoma in adults, 2L+, in combination with paclitaxel.
Manufacturer	Boston
Mechanism of action	Other
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)

Registration

Registration route	Centralised (EMA)
Submission date	2021
Expected Registration	2022
Registration phase	Clinical trials
Additional remarks	First-in-class cancer stemness inhibitor that targets STAT3. Resultaten fase III studie naar verwachting in 2021.

Therapeutic value

Therapeutic value	No judgement
Duration of treatment	Median 7 week / weeks
Frequency of administration	2 times a day
Dosage per administration	480 mg
References	Jonker et al. Lancet Gastroenterol Hepatol. 2018 Apr;3(4):263-270.

Expected patient volume per year

Patient volume	< 137 Market share is generally not included unless otherwise stated.
References	NKR
Additional remarks	In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer twee derde van deze patiënten werd behandeld in de 1e lijn (370 patiënten). Daarnaast werden 350 patiënten per jaar behandeld met palliatieve chemotherapie. Schatting voor percentage patiënten dat na progressie op 1e lijns systemische therapie start met 2e lijns systemische therapie is 37% (137 patiënten).

Patient volume

< 137

Market share is generally not included unless otherwise stated.

References

NKR

Additional remarks

In 2016 waren er gemiddeld 555 nieuwe patiënten met cardia of non-cardia maagadenocarcinoom stadium IV. Ongeveer twee derde van deze patiënten werd behandeld in de 1e lijn (370 patiënten). Daarnaast werden 350 patiënten per jaar behandeld met palliatieve chemotherapie. Schatting voor percentage patiënten dat na progressie op 1e lijns systemische therapie start met 2e lijns systemische therapie is 37% (137 patiënten).

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.