ZURICH, Jan 23 (Reuters) - European drug regulators have recommended approval for Roche Holding AG’s ROG.VX top-selling cancer drug MabThera to treat leukaemia, the Swiss drugmaker said on Friday.
The European Union’s Committee on Human Medicinal Products (CHMP) gave MabThera a positive recommendation for its use with any chemotherapy combination as a first-line treatment for chronic lymphocytic leukaemia (CLL).
CLL is the most common form of adult leukaemia amd accounts for around 20 to 25 percent of all forms of leukaemia and mainly affects the elderly, said Roche, which is the world’s largest maker of cancer drugs.
Recommendations for marketing approval by the CHMP are usually endorsed by the European Commission within a couple of months.
The label extension comes after the CLL8 study showed that the median time until patients progressed with their disease, had a relapse or died was 40 months if patients were given MabThera plus chemotherapy compared to 32 months for those that only received chemotherapy.
MabThera is already licensed for the treatment of non-Hodgkin’s lymphoma (NHL). (Reporting by Katie Reid; Editing by Mike Nesbit)