The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Celgene International's oral anti-cancer therapy Pomalidomide.
The positive results from the MM-003 study of oral pomalidomide have contributed for the positive opinion.
The study evaluated oral pomalidomide along with low-dose dexamethasone against high-dose dexamethasone in patients with relapsed and refractory multiple myeloma
Currently approved in the US under the brand name Pomalyst, the oral immunomodulatory agent is being reviewed in other countries.
Pomalidomide Celgene in combination with dexamethasone is submitted for approval to treat relapsed and refractory multiple myeloma (rrMM) patients with disease progression following a minimum of two therapies including both lenalidomide and bortezomib.
Celgene Europe, the Middle East and Africa (EMEA) president Alan Colowick said, "Following the final decision by the European Commission within the next few months, we hope to bring oral pomalidomide, Celgene's third and important treatment option for patients who have fully benefitted from other treatments including lenalidomide and need new options to help treat their disease."
