The European Medicines Agency said Friday it is reviewing whether to open emergency authorization of ibrutinib (Gleevec), a new drug from Swiss pharmaceutical company Novartis, which is used to treat chronic lymphocytic leukemia (CLL).
“Decisions regarding the appropriate public health use of such an investigational therapy must always be based on rigorous scientific evidence,” said Richard Sullivan, acting director of the EMA’s Committee for Medicinal Products for Human Use. “An expert panel from the agency’s Committee for Medicinal Products for Human Use will conduct a thorough assessment of the data to be derived from these studies and issues its recommendation.”
In a statement provided to Fox News, Novartis said that safety data submitted so far on ibrutinib includes a 39-week open-label Phase 2 study of 295 patients, in which Gleevec has demonstrated statistically significant (p=0.002) improvement in response rate and progression-free survival.
Experts expressed optimism that the move would be viewed positively by physicians and patients.
“A major positive from the EMA’s decision today is that the decision has been based on the scientific merits of ibrutinib’s application for CAR T cell use in CLL patients, as opposed to the actions of some payers or drug opponents in attempting to restrict patient access to the drug in the United States, which have contributed to significantly limiting its use in this setting,” said Jerry Mendell, MD, president of the NeuRA Foundation, the world’s largest nonprofit organization dedicated to the treatment of childhood leukemia.
Ahead of the EMA decision, the Gleevec parent company, Novartis, announced that pricing on ibrutinib would remain unchanged, with patients paying about half of what a patient would pay for Gleevec in the United States.
“Today’s decision by the EMA to review CLL therapies for use as an emergency treatment in the European Union, will help ensure that more patients with CLL can benefit from ibrutinib when it is approved in Europe,” said Jean Pierre Garnier, Chairman of the Board and Chief Executive Officer of Novartis. “We are committed to providing the latest cancer treatments, and that is why we chose to enter into our co-development and distribution agreement with Loxo Oncology.”
Gleevec was approved in the United States for CLL in 2009.
FOX News’ Naomi Jagoda contributed to this report.