Indikationer1
Lunsumio som monoterapi är avsett för behandling av vuxna patienter med recidiverande eller refraktärt follikulärt lymfom (FL), vilka tidigare har fått minst två linjer av systemisk behandling.
Clinical use:
The indication is granted market authorization based on objective response rate (ORR) demonstrated in a single-arm Phase II trial. Overall survival (OS) benefit in a single-arm trial cannot be confirmed.
In the pivotal trial, the majority of the clinical responses occurred within 16 weeks. Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Distribution Restrictions: ERIVEDGE is only available through a controlled distribution program called the ERIVEDGE Pregnancy Prevention Program (EPPP). For more information please contact the EPPP at 1-888-748-8926 or log onto rocheproplus.ca/en/products-resources/erivedge.html.
Geriatrics (≥65 years of age): Elderly patients should be treated with caution and monitored for adverse events.
Pediatrics (<18 years of age): The safety and efficacy of ERIVEDGE in pediatric patients has not been established. Irreversible premature fusion of the epiphyses and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. Premature fusion can progress after discontinuation of treatment. Due to safety concerns ERIVEDGE is contraindicated in children and adolescents aged below 18 years.
Contraindications:
Female patients who are pregnant or at risk of becoming pregnant
Breastfeeding female patients
Female patients of childbearing potential (FCBP) and male patients who do not comply with the ERIVEDGE Pregnancy Prevention Program
Children and adolescents aged less than 18 years of age
Patients who are hypersensitive to vismodegib or to any ingredient in the formulation
Most serious warnings and precautions:
Embryo-fetal death or severe birth defects: Can cause severe malformations, including craniofacial anomalies, midline defects and limb defects when administered to a female who is pregnant. Must not be used during pregnancy.
Effects on post-natal development: Irreversible premature fusion of the epiphyses (EPF) and precocious puberty have been reported in pediatric patients exposed to ERIVEDGE. In some cases of EPF, fusion progressed after drug discontinuation.
Renal impairment: The safety and efficacy of ERIVEDGE in patients with severe renal impairment have not been studied. No dedicated clinical studies have been conducted to evaluate the effect of mild, moderate and severe renal impairment on the pharmacokinetics of vismodegib.
Hepatic impairment: ERIVEDGE is not recommended for use in patients with severe hepatic impairment since limited data are available in these patients. ERIVEDGE should be used with caution in patients with mild and moderate hepatic impairment.
Other relevant warnings and precautions:
Effects on post-natal development
Blood donation: Patients must not donate blood while on treatment and for 24 months after discontinuation
Patients with advanced BCC (aBCC) have an increased risk of developing cutaneous squamous cell carcinoma (cuSCC). Cases of cuSCC have been reported in aBCC patients treated with ERIVEDGE. All patients should be monitored routinely while taking ERIVEDGE
Cardiovascular-related events
Decreased appetite, decreased weight and dehydration
Electrolyte abnormalities
Hepatotoxicity
Patients with a history of pancreatitis or gallbladder disease
Gastrointestinal-related events
Anaemia and lymphopenia
Grade 1 hypersensitivity
Arthralgia, back pain, muscle spasms, fractures, and elevated creatine phospohokinase (CPK) measurements reported
Syncope, dysgeusia and ageusia
Psychiatric disorders
Renal disorders and cases of renal failure have been observed in patients treated with ERIVEDGE
Amenorrhea has been observed in clinical trials in 30% of FCBP (Female of Childbearing Potential). Potential to impair fertility in patients
Blood work monitoring
For more information:
Please consult the Product Monograph for important information relating to warnings and precautions, adverse reactions, drug interactions, and dosing information that has not been discussed in this piece.
The Product Monograph is also available by calling us at 1-888-762-4388.
Verkningsmekanism1
Mosunetuzumab är en anti-CD20/CD3 bispecifik antikropp som målsöker CD20-uttryckande B-celler. Det är en agonist beroende av vissa förutsättningar; den inducerar B-cells-död endast vid samtidig bindning till CD20 på B-celler och till CD3 på T‑celler. Denna dubbelarmade bindning av mosunetuzumab resulterar i en tvärbindning mellan en mål-B-cell och en cytotoxisk T-cell som bildar en immunologisk synaps, vilket leder till aktivering av T-cellen. Den därefter riktade frisättningen av perforin och granzymer från T-cellsaktiveringen, via den immunologiska synapsen, inducerar B-cellslys med påföljande celldöd.
LUNSUMIO is a T-cell engaging bispecific antibody in 3L + FL
Dual Targeting
LUNSUMIO binds to and links CD20 on B cells and CD3 on T cells
Engage for Action
When both arms of LUNSUMIO are engaged, the T cell causes the release of proinflammatory cytokines and induces lysis of B cells.
Studiedesign1,2
An open-label, multicentre, multi-cohort Phase II study (GO29781) evaluated LUNSUMIO in patients with 3L+ relapsed/refractory FL
- Patients received step-up doses of LUNSUMIO intravenously as follows: 1 mg on Day 1 of Cycle 1, 2 mg on Day 8 of Cycle 1, 60 mg on Day 15 of Cycle 1, 60 mg on Day 1 of Cycle 2, and 30 mg on Day 1 of Cycle 3+
- 8 total cycles (~6 months) if CR was achieved, unless patients experienced progressive disease or unacceptable toxicity
- 17 total cycles (~12 months) if PR/SD was achieved after 8 cycles, unless patients experienced progressive disease or unacceptable toxicity
- 21 days/cycle
* Multicohort study for r/r B-cell lymphoma
Referenser
1. LUNSUMIO produktresumé www.fass.se
2. Budde LE, Sehn LH, Matasar M, et al. Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: a single-arm, multicentre, phase 2 study. Lancet Oncol. Published online July 5, 2022. doi:10.1016/S1470-2045(22)00335-7.
Effekt1
6/10 of patients achieved a complete response with LUNSUMIO (n=90)
63,7 % patients who achieved complete response maintained response at 18 months
(95% CI) (48.0; 79.4)
a Neutropeni inkluderar neutropeni och minskat antal neutrofiler
b Trombocytopeni inkluderar trombocytopeni och minskat antal blodplättar
c Enligt American Society for Transplant and Cellular Therapy
d I överensstämmelse med det medicinska konceptet av ICANS, enligt American Society for Transplant and Cellular Therapy och inkluderar förvirringstillstånd, ICANS, letargi, encefalopati, sänkt medvetandegrad och försämrat minne
e Frekvensberäkningen baseras på ytterligare kliniska studier
Dosering och administrering1
Fixed treatment duration
Information till patienter som ska få behandling med LUNSUMIO (mosunetuzumab)
▼Detta läkemedel är föremål för utökad övervakning. Detta kommer att göra det möjligt att snabbt identifiera ny säkerhetsinformation.
LUNSUMIO® ▼(mosunetuzumab), 1 mg och 30 mg koncentrat till infusionsvätska, lösning. Fullängds-isotyp av humaniserad anti-CD20/CD3-immunglobulin (Ig)G1. L01FX25 (Rx, EF).
Indikationer: LUNSUMIO som monoterapi är avsett för behandling av vuxna patienter med recidiverande eller refraktärt follikulärt lymfom (FL), vilka tidigare har fått minst två linjer av systemisk behandling.
Kontraindikationer: Överkänslighet mot den aktiva substansen eller mot något hjälpämne som ingår i lösningen.
Varningar och försiktighet: För att underlätta spårbarhet av biologiska läkemedel ska läkemedlets namn och tillverkningssatsnummer dokumenteras. Cytokinfrisättningssyndrom (CRS) inklusive hemofagocyterande lymfohistiocytos (HLH), allvarliga infektioner, immuneffektorcell-associerat neurotoxicitetssyndrom (ICANS), tumörexacerbation/”Tumor flare reaction” (TFR), tumörlyssyndrom (TLS) och immunisering. För ingående beskrivning av varningar och försiktighet se www.fass.se.
Datum för översyn av produktresumén: 2025-04-14.
För fullständig information vid förskrivning, produktresumé och aktuella priser, se www.fass.se.
Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning. Rapporteringen ska göras till Läkemedelsverket www.lakemedelsverket.se eller direkt till Roche på sverige.safety@roche.com.
Roche AB | Box 1228 | 171 23 Solna
Tel 08-726 12 00
www.roche.se