Osimertinib

Extended indication	Extension of indication to include treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
Therapeutic value	No estimate possible yet
Registration phase	Registration application pending

Product

Active substance	Osimertinib
Domain	Oncology
Reason of inclusion	Indication extension
Main indication	Lung cancer
Extended indication	Extension of indication to include treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy.
Proprietary name	Tagrisso
Manufacturer	AstraZeneca
Portfolio holder	AstraZeneca
Mechanism of action	Tyrosine kinase inhibitor
Route of administration	Oral
Therapeutical formulation	Tablet
Budgetting framework	Intermural (MSZ)

Registration route	Centralised (EMA)
ATMP	No
Submission date	April 2024
Expected Registration	February 2025
Orphan drug	No
Registration phase	Registration application pending

Therapeutic value	No estimate possible yet
References	NCT03521154

There is currently nothing known about the expected patient volume.

Additional remarks	€5.642,50 per 30 tabletten.

There is currently nothing known about the possible total cost.

There is currently nothing known about off label use.

There is currently nothing known about indication extensions.

There is currently no futher information available.