Europe’s Regulatory Commission (EC) has been busy lately. Sort of like our FDA, the EC approved a broader use of Velcade, then gave the green light for use of Pomalyst in relapsed patients:
Decision could significantly improve transplant outcomes for patients with multiple myeloma
Beerse, Belgium, 8th August 2013 – Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved the use of VELCADE® (bortezomib) as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD). This licence extension will apply to adult patients with previously-untreated myeloma who are eligible for high-dose chemo with haematological stem cell transplantation.
Until now, VELCADE’s (bortezomib) indication has been limited to its use, in combination with melphalan and prednisone, in adult patients with multiple myeloma that are previously untreated and ineligible for stem cell transplant, and as a single agent in advanced multiple myeloma. Multiple myeloma, a type of blood cancer, currently affects around 60,000 people in Europe. This decision could mean significantly improved outcomes for many patients with this disease.
The approval by the EC was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM05) which demonstrated that treatment with VELCADE-based induction resulted in improvements in post-induction and post-transplant response rates and in progression-free survival (PFS); PFS and overall survival (OS) were secondary endpoints.
The trials studied the use of VELCADE-based regimens VD and VTD, compared to non-VELCADE-based regimens of vincristine plus doxorubicin and dexamethasone, or thalidomide and dexamethasone, respectively, as induction therapy prior to autologous stem cell transplant in adult patients with previously-untreated multiple myeloma.
Celgene receives EU approval for new myeloma drug
August 9, 2013 in Pharmaceutical Company Product News
Celgene has announced that it has received European Commission approval for its new blood cancer drug pomalidomide.
The regulatory body has ratified the compound for use in combination with dexamethasone for adult patients with relapsed and refractory multiple myeloma who have have demonstrated disease progression despite receiving at least two prior therapies, including both lenalidomide and bortezomib.
Data from the phase III trial MM-03 that demonstrated the drug’s progression-free survival benefits formed the basis of the European Commission’s decision.
Following this announcement, Celgene plans to launch the product in Europe under the trade name Imnovid.
Alan Colowick, president of Celgene in Europe, the Middle East and Africa, said: “With today’s approval, Celgene becomes one of the few companies to deliver treatments across all stages of multiple myeloma, right from the start at diagnosis.”
This comes after the firm announced positive trial data earlier this week that showed the benefits its drug Revlimid can offer in the treatment of smouldering multiple myeloma.
It’s great to know that our myeloma brothers and sisters across the pond will be benefiting from expanded approval of anti-myeloma meds, too. Keep ‘em coming!
Feel good and keep smiling! Pat