The European Commission has approved two of Celgene’s IMiD ^® -based combination regimens:

• Lenalidomide (Revlimid^®) in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant
• Pomalidomide (Imnovid^®) in combination with bortezomib and dexamethasone (PVd), in adult patients with multiple myeloma, who have received at least one prior treatment regimen including lenalidomide.

Lenalidomide in combination with bortezomib and dexamethasone (RVd) is now indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. In addition pomalidomide in combination with bortezomib and dexamethasone (PVd), is now indicated for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

The choice of treatment in a first-line therapy setting is important as patients progressively become less responsive to therapy, and experience shorter periods of remission at later lines of treatment. Studies have shown that RVd can provide newly diagnosed patients that are not eligible for a transplant with a treatment option that significantly prolongs the first remission.

“Determining first-line therapy is an important consideration in the overall treatment plan for patients with multiple myeloma,” said Prof. Thierry Facon, Professor of Haematology in the Department of Haematology, Lille University Hospital, France. “Since lenalidomide in combination with dexamethasone is already a standard of care in multiple myeloma, we’re excited by the prospect of a new lenalidomide-based triplet option for previously untreated patients who are not eligible for transplant.”

The approval for the lenalidomide triplet (RVd) was supported by data from SWOG S0777, a phase 3 trial evaluating the triplet combination, RVd, in adult patients with previously untreated multiple myeloma.

“Today’s approval for use of the pomalidomide-containing triplet, PVd, as early as first relapse, underscores the potential clinical benefit this regimen can provide to patients following a prior treatment including lenalidomide,” said Prof. Meletios Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics at the University Athens School of Medicine, Athens, Greece. “Lenalidomide-based regimens are often used as a standard of care in newly diagnosed multiple myeloma patients, and there is a growing patient population who become refractory to lenalidomide and need proven treatment options.”

The approval of the pomalidomide triplet (PVd) was supported by data from OPTIMISMM⁴, the first prospective phase 3 trial to evaluate a pomalidomide-based triplet regimen in patients who were all previously treated with lenalidomide, and the majority (70%) of patients were lenalidomide refractory. Results from OPTIMISMM were recently published in The Lancet Oncology.