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REVLIMID® and rituximab (R2) has the abeyant to become a chemotherapy-free aggregate assay advantage for patients with follicular lymphoma who accept relapsed or did not acknowledge to antecedent treatment
The absolute assessment was based on the after-effects of the Phase 3 AUGMENT study, which showed the R2 dieting conferred a statistically decidedly advance in progression-free adaptation against rituximab monotherapy
SUMMIT, NJ, USA I November 15, 2019 I Celgene Corporation (NASDAQ:CELG) today arise that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a absolute opinion, advising the approval of REVLIMID® (lenalidomide) in aggregate with rituximab (anti-CD20 antibody) (R²) for the assay of developed patients with ahead advised follicular lymphoma (FL) (Grade 1-3a). If accustomed by the European Commission (EC), R2 will be the aboriginal aggregate assay dieting for patients with FL that does not accommodate chemotherapy.
“Since its antecedent approval in 2007, REVLIMID has connected to authenticate its allowances beyond a ambit of austere claret disorders in Europe and a CHMP absolute assessment for this aggregate with rituximab is actual acceptable account for patients with follicular lymphoma. We attending avant-garde to the European Commission decision,” said Tuomo Pätsi, President of Hematology/Oncology for Celgene Worldwide Markets.
In FL, a subtype of blah NHL, the allowed arrangement is not activity optimally.1,2 Back this dysfunction occurs, the allowed arrangement either fails to ascertain or advance annihilative cells.1,2 Rituximab is a monoclonal antibiotic that targets the CD 20 antigen on the apparent of pre-B and complete B-lymphocytes. Upon bounden to CD20, rituximab causes B-cell lysis. Lenalidomide is an immunomodulator that increases the cardinal and activation of T and accustomed analgesic (NK) cells, consistent in the lysis of bump cells. The R2 aggregate dieting acts by commutual mechanisms to advice the patient’s allowed arrangement to acquisition and abort the blight cells.3
Given the cureless attributes of FL2, a aerial unmet medical charge exists for the development of atypical assay options with new mechanisms of activity and a tolerable assurance contour to advice advance progression-free adaptation (PFS) abnormally in the ambience of ahead advised FL.
The estimated accident of NHL in Europe was 100,055 cases in 2018; FL accounts for about 25% of all NHL cases and is the best accepted anatomy of blah NHL.3,4,5
“Chemotherapy is a accepted of affliction for blah forms of NHL, but best patients will backsliding or become adverse to their accepted treatment,” said Prof. John Gribben, President of EHA and Centre for Haemato-Oncology, Barts Blight Institute, in England “The aggregate of REVLIMID and rituximab could represent a new, chemotherapy-free assay advantage for patients with ahead advised follicular lymphoma.”
The CHMP absolute assessment is based primarily on after-effects from the randomized, multi-center, double-blind, Phase 3 AUGMENT study, which evaluated the ability and assurance of the R² aggregate against rituximab added placebo in patients with ahead advised FL (n=295).6,7 Additionally, allegation from the MAGNIFY abstraction were included as abutment for the assurance and the ability of lenalidomide added rituximab in patients with relapsed or adverse FL, including rituximab adverse FL patients.8
The CHMP reviews applications for all affiliate states of the European Union (EU), as able-bodied as Norway, Liechtenstein, and Iceland. The European Commission, which about follows the advocacy of the CHMP, is accepted to accomplish its final accommodation in about two months. If approval is granted, abundant altitude for the use of this artefact will be declared in the REVLIMID Summary of Artefact Characteristics (SmPC), which will be arise in the revised European Public Assessment Report (EPAR).
About Follicular Lymphoma
Lymphoma is a claret blight that develops in lymphocytes, a blazon of white claret corpuscle in the allowed arrangement that helps assure the anatomy from infection.9 There are two classes of lymphoma – Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL) – anniversary with specific subtypes that actuate how the blight behaves, spreads and should be treated.3,10,11 Added appropriate factors of lymphomas are what blazon of lymphocyte is afflicted (T corpuscle or B cell) and how complete the beef are back they become cancerous.11
Follicular lymphoma is the best accepted blah (slow-growing) anatomy of NHL, accounting for about 25% of all Non-Hodgkin lymphoma (NHL) patients.5,12 Best patients present with avant-garde ache usually back lymphoma-related affection arise (e.g., nodal disease, B symptoms, cytopenia) and accept systemic chemoimmunotherapy.5 While follicular lymphoma patients are about acknowledging to antecedent treatment, the ache advance is characterized by alternate relapses over time with beneath absolution periods.13
AUGMENT is a Phase 3, randomized, double-blind analytic balloon evaluating the ability and assurance of REVLIMID® (lenalidomide) in aggregate with rituximab (R²) against rituximab added placebo in patients with ahead advised follicular lymphoma (FL). AUGMENT included patients diagnosed with Grade 1, 2 or 3a FL, who were ahead advised with at atomic 1 above-mentioned systemic assay and two antecedent doses of rituximab. Patients were accurate relapsed, adverse or accelerating ache afterward systemic therapy, but were not rituximab-refractory.6,7
The primary endpoint was progression-free survival, authentic as the time from date of randomization to the aboriginal ascertainment of ache progression or afterlife due to any cause. Secondary and basic endpoints included all-embracing acknowledgment rate, abiding complete acknowledgment rate, complete acknowledgment rate, continuance of response, continuance of complete response, all-embracing survival, event-free adaptation and time to abutting anti-lymphoma therapy.6,7
REVLIMID is accustomed in Europe and the United States as monotherapy, adumbrated for the aliment assay of developed patients with anew diagnosed assorted myeloma (MM) who accept undergone autologous axis corpuscle transplantation. REVLIMID as aggregate assay is accustomed in Europe, in the United States, in Japan and in about 25 added countries for the assay of developed patients with ahead basic MM who are not acceptable for transplant. REVLIMID is additionally accustomed in aggregate with dexamethasone for the assay of patients with MM who accept accustomed at atomic one above-mentioned assay in about 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in aggregate with dexamethasone for the assay of patients whose ache has progressed afterwards one assay in Australia and New Zealand.
REVLIMID is additionally accustomed in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as able-bodied as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a abatement 5q cytogenetic aberancy with or afterwards added cytogenetic abnormalities and in Europe for the assay of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an abandoned abatement 5q cytogenetic aberancy back added ameliorative options are bereft or inadequate.
In addition, REVLIMID is accustomed in Europe for the assay of patients with crimson corpuscle lymphoma (MCL) and in the United States for the assay of patients with MCL whose ache has relapsed or progressed afterwards two above-mentioned therapies, one of which included bortezomib. In Switzerland, REVLIMID is adumbrated for the assay of patients with relapsed or adverse MCL afterwards above-mentioned assay that included bortezomib and chemotherapy/rituximab.
REVLIMID is not adumbrated and is not recommended for the assay of patients with abiding lymphocytic leukemia (CLL) alfresco of controlled analytic trials.
Celgene Corporation, headquartered in Summit, New Jersey, is an chip all-around biopharmaceutical aggregation affianced primarily in the discovery, development and commercialization of avant-garde therapies for the assay of blight and anarchic diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For added information, amuse appointment Media Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
1 Scott DW, Gascoyne RD. The tumour microenvironment in B corpuscle lymphomas. Nat Rev Cancer. 2014;14(8):517-534.
2 Kridel R, Sehn LH, Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest. 2012;122(10):3424-3431.
3 Chiu H, Trisal P, Bjorklund C, et al. Aggregate lenalidomide-rituximab immunotherapy activates anti-tumour amnesty and induces tumour corpuscle afterlife by commutual mechanisms of activity in follicular lymphoma. Br J Haematol. 2019;185(2):240-253.
4 European Blight Advice System. Estimates of blight accident and bloodshed in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed August 2019.
5 European Society for Medical Oncology. Follicular Lymphoma: A Guide for Patients. 2014. Available at: Media . Accessed September 2019.
6 Leonard JP, Trneny M, Izutsu K, et al. AUGMENT: A Phase III Abstraction of Lenalidomide Added Rituximab Against Placebo Added Rituximab in Relapsed or Adverse Blah Lymphoma. J Clin Oncol. 2019;10;37(14):1188-1199.
7 ClinicalTrials.gov Rituximab Added Lenalidomide for Patients With Relapsed / Adverse Blah Non-Hodgkin’s Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT). Available at: https://clinicaltrials.gov/ct2/show/NCT01938001 Accessed September 2019.
8 ClinicalTrials.gov Lenalidomide Added Rituximab Followed by Lenalidomide Against Rituximab Aliment for Relapsed/Refractory Follicular, Marginal Zone or Crimson Corpuscle Lymphoma (MAGNIFY). Available at: https://clinicaltrials.gov/ct2/show/NCT01996865 Accessed August 2019.
9 American Blight Society. Lymphoma. Available at: Media Accessed August 2019.
10 American Blight Society. What is Hodgkin Lymphoma? Available at: Media Accessed August 2019.
11 American Blight Society. What is Non-Hodgkin Lymphoma? Available at: Media Accessed August 2019.
12 Lymphoma Action. Follicular lymphoma. Available at: Media Accessed November 2019.
13 Montoto S, Lopez-Guillermo A, Ferrer A, et al. Adaptation afterwards progression in patients with follicular lymphoma: assay of anxiety factors. Ann Oncol. 2002;13(4):523-30.
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