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Polatuzumab vedotin

Extended indication Previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hema
Therapeutic value Possible added value
Registration phase Registration application pending

Product

Active substance Polatuzumab vedotin
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant
Manufacturer Roche
Mechanism of action Antibody-drug conjugate
Route of administration Intravenous
Therapeutical formulation Powder for solution for infusion
Budgetting framework Intermural (MSZ)
Additional remarks CD79b-targeted antibody drug conjugate that preferentially delivers a potent anti-mitotic agent (monomethyl auristatin E, or MMAE) to B-cells, resulting in anticancer activity against B-cell malignancies.

Registration

Registration route Centralised (EMA)
Type of trajectory Accelerated assessment
Particularity New medicine with Priority Medicines (PRIME)
Submission date January 2019
Expected Registration September 2019
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Fabrikant verwacht in het gunstigste geval een registratie in Q4 2019.

Therapeutic value

Current treatment options geen
Therapeutic value Possible added value
Substantiation Verbeterde PFS en OS ten opzichte van bendamustine+rituximab.
Frequency of administration 1 times every 3 weeks
Dosage per administration 1.8 mg/kg
References NCT03274492,Sehn et al 2018 Studie: GO29365
Additional remarks Phase III: Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m^2) IV, cyclophosphamide 750 mg/m^2 IV, and doxorubicin 50 mg/m^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m^2 IV will be administered as monotherapy in Cycles 7 and 8. Toelichting fabrikant: "In de internationale studie wordt bendamustine+rituximab als vergelijkende arm gebruikt, aangezien dit op internationaal niveau een veelgebruikte (maar niet geregistreerde) combinatie is. Behandelduur nog onbekend op basis van huidige resultaten, maar is maximaal 6 behandelcycli."

Expected patient volume per year

Patient volume

< 250

Market share is generally not included unless otherwise stated.
References Beoordeling ibrutinib. Zorginstituut Nederland
Additional remarks De incidentie van DLBCL (en varianten) in Nederland in 2015 was 1.214 patiënten. Ongeveer 40% van de patiënten reageert niet op de eerste lijnsbehandeling. Ongeveer 50% van de patienten wordt in de tweedelijn behandeld met autologe stamceltransplantatie. Dit betekent dat 50% van de patienten in aanmerking zou komen voor behandeling met polatuzumab vedotin.

Expected cost per patient per year

Additional remarks Over de prijs van polatuzumab vedotin is nog geen informatie beschikbaar.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

Off label use No
References Fabrikant

Indication extension

Indication extension Yes
Indication extensions Er zijn studies gaande naar eerstelijns behandeling DLBCL en relapsed/refractair folliculair lymfoom
References clinicaltrials.gov

Other information

There is currently no futher information available.