Polatuzumab vedotin

Extended indication	Previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant
Therapeutic value	Possible added value
Registration phase	Clinical trials

Product

Active substance	Polatuzumab vedotin
Domain	Oncology and Hematology
Reason of inclusion	New medicine (specialité)
Main indication	Lymphoma
Extended indication	Previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant
Manufacturer	Roche
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	2019
Expected Registration	November 2019
Orphan drug	Yes
Registration phase	Clinical trials
Additional remarks	Fabrikant: "Polatuzumab vedotin is aangemerkt voor een PRIME designation door de EMA. Registratie in Q4 2019 is best case scenario".

Therapeutic value

Current treatment options	EMA: "The main treatment was chemotherapy (medicines to treat cancer) usually in combination with medicines called monoclonal antibodies and sometimes with radiotherapy (treatment with radiation). Autologous haematopoietic (blood) stem-cell transplantation was also used in patients at risk of the disease coming back after treatment. This procedure involves replacing the patient's bone marrow with the patient's own stem cells to form new bone marrow that produces healthy blood cells."
Therapeutic value	Possible added value
Substantiation	EMA: "the sponsor has provided sufficient information to show that the medicine might be of significant benefit for patients with diffuse large B-cell lymphoma because early results suggest that adding polatuzumab vedotin to existing treatments improved their effectiveness in patients whose disease had come back or in whom other treatment had not worked well enough." Fabrikant: "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."

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.

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	No
References	clinicaltrials.gov
Additional remarks	Op dit moment geen fase III studies voor andere indicaties. Wel zijn er nog andere studies gaande naar de eerstelijns behandeling DLBCL en relapsed/refractair folliculair lymfoom.

Other information

There is currently no futher information available.