Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology Regulatory

 News Release - July 15, 2016

REVLIMID(R) (Lenalidomide) Approved by the European Commission for the Treatment of Relapsed/Refractory Patients with Mantle Cell Lymphoma

BOUDRY, Switzerland--(Healthcare Sales & Marketing Network)--Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (CELG) today announced that the European Commission (EC) has approved REVLIMID® (lenalidomide) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

MCL is a rare sub-type of aggressive non-Hodgkin’s lymphoma (NHL), which starts in the lymph nodes but can move to other organs, causing tumours known as lymphomas. Between 3 and 6 percent of NHL patients have MCL. MCL has the poorest long-term survival of all B-cell lymphoma subtypes, with fewer than 50 percent of patients surviving at 5 years1. In Europe there were 93,433 new cases of non-Hodgkin lymphoma, and 37,900 deaths in 20122. MCL has a median age of onset of 70 years and affects men more often than women3.

“New treatment options are vitally needed in order to change the course of MCL for patients, given the severity of the disease, and there are still limited existing treatment options,” said Prof. Marek Trneny, Charles University in Prague. “Lenalidomide is a proven medicine that has shown efficacy in relapsed/refractory MCL, with the MCL-002 study meeting its primary endpoint of an improvement in progression-free survival (PFS).”

Tuomo Pätsi, President of Celgene in Europe, Middle East and Africa (EMEA), adds: “Today is an important milestone in the fight to find new treatment options for patients with MCL, a difficult-to-treat disease with a high unmet medical need. The approval by the European Commission for REVLIMID® in relapsed/refractory MCL gives us the opportunity to support patients in their fight against this disease, with an innovative treatment, and it is only the beginning of our work to support the needs of patients with MCL. We have a robust clinical program of lymphoma studies reaching patients across the globe with an aim to find new treatment options across numerous types of lymphoma.”

The EC decision was based on data from MCL-002, a phase II, multicenter, randomized open-label study to determine the efficacy and safety of REVLIMID® versus the investigator’s choice (IC), in 254 patients who were refractory to their last treatment or had relapsed one to three times. In the study, REVLIMID® showed a significant improvement in progression-free survival (PFS) of 8.7 months vs. 5.2 in the control arm (HR = 0.61, p value of .004)4.

In the study, the most frequently observed adverse reactions which occurred more frequently in the REVLIMID® arm compared with the IC arm were neutropenia (50.9%), anaemia (28.7%), diarrhoea (22.8%), fatigue (21.0%), constipation (17.4%), pyrexia (16.8%), and rash (16.2%).

The EC decision for the use of REVLIMID® in adult patients with relapsed/refractory MCL follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) earlier this year. The EC decision marks the 6th new product or indication granted to Celgene in the last 18 months in the European Union. In 2015, Celgene announced the EC approval of medicines for newly diagnosed multiple myeloma, another form of blood cancer; psoriasis and psoriatic arthritis; a specific subset of acute myeloid leukaemia (AML) patients; and non-small-cell lung cancer (NSCLC).

In addition to the EU approval, REVLIMID® is indicated for the treatment of patients with relapsed/refractory MCL in the United States, Switzerland, Israel, Turkey, Australia, and numerous countries in Latin America. REVLIMID® is also indicated in various countries including the EU for treatment of newly diagnosed and relapsed/refractory multiple myeloma and myelodysplastic syndromes.

IMPORTANT SAFETY INFORMATION

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID® during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID® treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID® treatment.


Source: Celgene

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