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Trilaciclib

Extended indication Protects patients with small cell lung cancer against multi-lineage chemotherapy-induced myelosuppre
Therapeutic value No estimate possible yet
Registration phase Clinical trials

Product

Active substance Trilaciclib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Protects patients with small cell lung cancer against multi-lineage chemotherapy-induced myelosuppression.
Manufacturer G1 therapeutics
Mechanism of action CDK4 / 6 tyrosine kinase inhibitor
Route of administration Intravenous
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Submission date 2022
Expected Registration 2023
Orphan drug No
Registration phase Clinical trials
Additional remarks Actual primary completion date in juli 2018. FDA breakthrough therapy.

Therapeutic value

Current treatment options In de toekomst ook ALRN6924 als myelosuppressie agent.
Therapeutic value No estimate possible yet
Frequency of administration 1 times a day
Dosage per administration 240 mg/m2
References NCT03041311; NCT02514447
Additional remarks Patients will receive trilaciclib 240mg/m2 administered Intraveneus once daily on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total).

Expected patient volume per year

Patient volume

< 427

Market share is generally not included unless otherwise stated.
References NKR; Chan, B. A. (2013). Chemotherapy advances in small-cell lung cancer. Journal of thoracic disease, 5 Suppl 5(Suppl 5).
Additional remarks In Nederland is er in 2017 bij 1.709 personen kleincellige longkanker geconstateerd. Bij het merendeel van de patiënten met kleincellige longkanker is op het moment van de diagnose de ziekte al uitgezaaid. Als er sprake is van uitgebreide ziekte volgt er chemotherapie. In dit geval ontwikkelt ~25% van de patiënten myelosuppressie. Dit zou betekenen dat 427 patiënten in aanmerking zouden kunnen komen. Het is op dit moment nog niet duidelijk of trilaciclib ook daadwerkelijk in de praktijk ingezet zal worden.

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

Indication extension Yes
Indication extensions Breast cancer.
References Adisinsight.
Additional remarks Fase 2 studie.

Other information

There is currently no futher information available.