Extended indication Patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy
Therapeutic value Possible equal value
Registration phase Clinical trials

Product

Active substance Ensartinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Lung cancer
Extended indication Patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
Manufacturer Betta Pharmaceuticals
Mechanism of action Other, see general comments
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)
Additional comments Anaplastic lymphoma kinase inhibitors; EphA2 receptor antagonist; Proto oncogene protein c met inhibitor; ROS1 protein inhibitors; TrkA receptor antagonist; TrkC receptor antagonist.

Registration

Registration route Centralised (EMA)
Submission date 2021
Expected Registration 2022
Orphan drug No
Registration phase Clinical trials
Additional comments Indieningsdatum op basis van primary completion datum fase 3 studie in maart 2021.

Therapeutic value

Current treatment options Lorlatinib en alectinib.
Therapeutic value Possible equal value
Substantiation Er wordt verwacht dat ensartinib een plaats zal krijgen naast de twee huidige behandelopties en dat de markt verdeeld zal worden. Uit de resultaten van de trial kwam een mediane PFS van 25,8 maanden (95% CI, 21.8–not reached [NR]) versus 12.7 maanden (95% CI, 9.2-6.6) in de (ITT) populatie (hazard ratio [HR], 0.51; 95% CI, 0.35-0.72; P = .0001).
Dosage per administration 225mg
References NCT02767804

Expected patient volume per year

Patient volume

< 141

Market share is generally not included unless otherwise stated.

References NKR; Pakketadvies Atezolizumab; Korpanty et al. Front Oncol. 2014; 4: 204.; GIPdatabank; Tiseo et al. Lung Cancer. 2011 Feb;71(2):241-3.; record brigatinib.
Additional comments In 2018 waren er 5.062 patiënten met NSCLC stadium IV. Hiervan is 5% ALK+ (225). Aannemende dat 70% getest wordt (158), 20% van de ALK+ patiënten geïncludeerd wordt in studies, en 80% van de resterende patiënten een eerstelijns ALK TKI krijgen (141). De verwachting is dat de markt verdeeld zal worden over lorlatinib, alectinib en ensartinib.

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 CNS cancer; Malignant melanoma; Non-Hodgkin's lymphoma; Solid tumours
References Adis insight

Other information

There is currently no futher information available.