Celgene International Sàrl (NASDAQ: CELG) was notified today that the E.U. Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA) has concluded an Article 20 review of REVLIMID® and issued a positive opinion for the use of REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The Article 20 procedure was initiated following reports of a low incidence of second primary malignancies (SPM) from clinical studies.
In their completion of the Article 20 Review, the CHMP concluded that REVLIMID in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy demonstrates a positive benefit-risk profile. The CHMP also recommended that the product information for REVLIMID be updated to include information on SPMs.
This concludes the Article 20 review of clinical data in the approved indication for REVLIMID, including pivotal studies MM-009 and MM-010, as well as a comprehensive analysis of the occurrence of SPMs in Celgene safety data and international patient databases. The analysis demonstrated the use of continuous REVLIMID/dexamethasone in the relapsed/refractory multiple myeloma (RRMM) setting was associated with a confirmed response rate, progression-free survival and overall survival benefit, while the incidence rate of invasive SPMs (hematological malignancies and solid tumors) observed in the pivotal studies was low, and within the expected background rate for this patient population.
This CHMP opinion was based on extensive analyses of Celgene data in previously treated and newly diagnosed multiple myeloma patients. Of note, the analyses for newly diagnosed multiple myeloma confirmed there was no correlation between treatment duration with REVLIMID and the risk of SPMs. Previous analyses presented earlier this year at the International Myeloma Workshop (IMW) have also demonstrated no correlation between treatment duration with REVLIMID and the risk of SPMs for patients previously treated for multiple myeloma.
Celgene International Sàrl