BOUDRY, Switzerland I December 19, 2014 I Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for continuous oral treatment with REVLIMID® in adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).
Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. 1 It is a rare but deadly disease: around 38,900 people were newly diagnosed with multiple myeloma in Europe in 2012, and 24,300 people died from the disease in the same year. 2 On average, multiple myeloma is diagnosed between 65-74 years of age. 3 The majority of newly diagnosed patients are not eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant,4 and there is currently no therapy option approved for continuous treatment to help manage the disease over the long term. 5
“When recommending a therapy at first diagnosis, our aim is to keep the disease under control for as long as possible,” says Professor Thierry Facon, Services des Maladies du Sang, Hôpital Claude Huriez, and CHRU Lille, France. “The positive opinion for REVLIMID for the continuous treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant is a significant step towards bringing a new therapy that could extend the time patients live without their disease progressing.”
The anticipated European Commission decision would be the latest milestone for Celgene’s flagship product in Europe and its continued focus on delivering innovative medicines for rare haematological diseases. REVLIMID is already indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. REVLIMID is also indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “The CHMP opinion reflects the important role that therapies like REVLIMID play in treating rare haematological cancers including multiple myeloma. Innovative medicines have been critical in helping to improve patient outcomes, but despite tremendous progress over the last 10 years, myeloma remains incurable for the vast majority of patients, so new treatments are needed. At Celgene, we will continue to invest more than one-third of our revenues back into research and development to continue finding new treatment options for these patients. Our hope is that one day, deadly diseases like multiple myeloma could become a manageable, long-term chronic condition.”
The CHMP recommendation in newly diagnosed multiple myeloma was based on the results of two pivotal studies: MM-015 and MM-020 (also known as FIRST). The results of these studies have been reported previously.
The FIRST study, MM-020,6 was the largest phase III, randomised study of 1,623 patients newly diagnosed with multiple myeloma and not eligible for stem cell transplantation. It compared lenalidomide–dexamethasone (Rd) administered in 28-day cycles until disease progression, with Rd for 72 weeks (18 cycles), and melphalan–prednisone–thalidomide (MPT) for 72 weeks.
MM-0157 was a phase III study of 459 patients that compared melphalan–prednisone–lenalidomide induction followed by lenalidomide maintenance (MPR-R) with melphalan–prednisone–lenalidomide (MPR) or melphalan–prednisone (MP) followed by placebo in patients ≥65 years or older with newly diagnosed multiple myeloma.
REVLIMID is not currently indicated for the treatment of newly diagnosed multiple myeloma in any country.
About REVLIMID®
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
In addition, REVLIMID is approved in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.
SOURCE: Celgene
Post Views: 79
BOUDRY, Switzerland I December 19, 2014 I Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for continuous oral treatment with REVLIMID® in adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).
Multiple myeloma is a persistent and life-threatening blood cancer that is characterised by tumour proliferation and suppression of the immune system. 1 It is a rare but deadly disease: around 38,900 people were newly diagnosed with multiple myeloma in Europe in 2012, and 24,300 people died from the disease in the same year. 2 On average, multiple myeloma is diagnosed between 65-74 years of age. 3 The majority of newly diagnosed patients are not eligible for more aggressive treatment options such as high-dose chemotherapy with stem cell transplant,4 and there is currently no therapy option approved for continuous treatment to help manage the disease over the long term. 5
“When recommending a therapy at first diagnosis, our aim is to keep the disease under control for as long as possible,” says Professor Thierry Facon, Services des Maladies du Sang, Hôpital Claude Huriez, and CHRU Lille, France. “The positive opinion for REVLIMID for the continuous treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant is a significant step towards bringing a new therapy that could extend the time patients live without their disease progressing.”
The anticipated European Commission decision would be the latest milestone for Celgene’s flagship product in Europe and its continued focus on delivering innovative medicines for rare haematological diseases. REVLIMID is already indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. REVLIMID is also indicated for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
Tuomo Pätsi, President of Celgene in Europe, the Middle East and Africa (EMEA), said, “The CHMP opinion reflects the important role that therapies like REVLIMID play in treating rare haematological cancers including multiple myeloma. Innovative medicines have been critical in helping to improve patient outcomes, but despite tremendous progress over the last 10 years, myeloma remains incurable for the vast majority of patients, so new treatments are needed. At Celgene, we will continue to invest more than one-third of our revenues back into research and development to continue finding new treatment options for these patients. Our hope is that one day, deadly diseases like multiple myeloma could become a manageable, long-term chronic condition.”
The CHMP recommendation in newly diagnosed multiple myeloma was based on the results of two pivotal studies: MM-015 and MM-020 (also known as FIRST). The results of these studies have been reported previously.
The FIRST study, MM-020,6 was the largest phase III, randomised study of 1,623 patients newly diagnosed with multiple myeloma and not eligible for stem cell transplantation. It compared lenalidomide–dexamethasone (Rd) administered in 28-day cycles until disease progression, with Rd for 72 weeks (18 cycles), and melphalan–prednisone–thalidomide (MPT) for 72 weeks.
MM-0157 was a phase III study of 459 patients that compared melphalan–prednisone–lenalidomide induction followed by lenalidomide maintenance (MPR-R) with melphalan–prednisone–lenalidomide (MPR) or melphalan–prednisone (MP) followed by placebo in patients ≥65 years or older with newly diagnosed multiple myeloma.
REVLIMID is not currently indicated for the treatment of newly diagnosed multiple myeloma in any country.
About REVLIMID®
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.
In addition, REVLIMID is approved in the United States for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.
SOURCE: Celgene
Post Views: 79
