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Aumolertinib (mesilate)

Extended indication EGFR-mutated non–small cell lung cancer (NSCLC) and locally advanced or metastatic EGFR T790M mutati
Therapeutic value Possible equal value
Registration phase Registration application pending

Product

Active substance Aumolertinib (mesilate)
Domain Oncology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication EGFR-mutated non–small cell lung cancer (NSCLC) and locally advanced or metastatic EGFR T790M mutation–positive NSCLC.
Manufacturer EQRx
Route of administration Oral
Budgetting framework Intermural (MSZ)
Additional remarks Werkingsmechanisme: EEGFR antagonists

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date December 2022
Expected Registration January 2025
Orphan drug No
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van IHSI-inschatting.

Therapeutic value

Current treatment options erlotinib, gefitinib, afatinib, dacomitinib en osimertinib
Therapeutic value Possible equal value
Substantiation Er wordt een gelijke waarde met osimertinib verwacht op basis van de non-inferioriteitsstudie.
Frequency of administration 1 times a day
Dosage per administration 110 mg/55 mg
References NCT03849768
Additional remarks Klinische studie: The initial dose 110mg once daily can be reduced to 55mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Expected patient volume per year

Patient volume

210 - 420

Market share is generally not included unless otherwise stated.
References NKR; Pakketadvies Atezolizumab; Ned Tijdschr Geneeskd. 2011;155:A2554; expertopinie; PALGA database
Additional remarks Jaarlijks presenteren er ongeveer 7.500 patiënten per jaar met NSCLC stadium IIIb/IV. Het aantal NSCLC patiënten met EGFR mutaties in de eerste lijn is ongeveer 5 tot 10% (375 tot 750). In de praktijk zullen niet alle patiënten vanwege co-morbiditeit in aanmerking komen voor een behandeling, maar ongeveer 80% (300 tot 600). Verder is het testgehalte voor mutaties volgens de PALGA database 70%. Dit brengt het totale aantal patiënten op 210 tot 420.

Expected cost per patient per year

References Expertopinie
Additional remarks Er wordt verwacht dat de kosten van aumolertinib lager zullen uitvallen dan concurrent osimertinib.

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

Indication extension No
References Adis Insight
Additional remarks Niet op korte termijn, fase 1 studie solide tumoren

Other information

There is currently no futher information available.