Dear REVLIMID G3M Colleagues,

It’s with great excitement that we share the news that the REVLIMID^® triplet—REVLIMID with bortezomib and dexamethasone (RVd)—is now approved in the EU, by the European Commission (EC) for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant.

The EU approval of the REVLIMID triplet was based on the data from SWOG S0777—a phase 3 trial evaluating the safety and efficacy of RVd compared to Rd in adult patients with previously untreated MM without an intent for immediate transplant. This trial further adds to Celgene’s body of work with REVLIMID in MM and demonstrates the important role that REVLIMID may play in the treatment of patients with NDMM.

Previously untreated NSCT patients may be able to achieve unprecedented overall survival (OS) of over 7 years, with a significant increase in median OS of almost 2 years vs Rd (89.1 vs 67.2 months; HR 0.72, 95% CI 0.56–0.94; P=0.013).

The REVLIMID triplet also demonstrated progression-free survival (PFS) of over 3 years and an increase of median PFS by 1 year vs Rd (41.7 vs 29.7 months; HR 0.76, 95% CI 0.62–0.94; P=0.010). The safety of RVd is consistent with the well-established safety profiles of each drug in the triplet therapy.

The expanded indication for REVLIMID offers another treatment option for patients and their healthcare providers in the EU and improves the expected outcomes for multiple myeloma patients. We thank you for what you are about to do to make RVd a reality for patients in the EU and for your continued dedication towards furthering our search for a cure in MM.

Sincerely,
[REVLIMID G3M Leads]

The approved EU indication, effective as of [DATE], states: “REVLIMID as combination therapy with dexamethasone, with bortezomib and dexamethasone, or with melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma (MM) who are not eligible for transplant.”