Janssen-Cilag International NV announced today that the Committee for
Medical Products for Human Use (CHMP) of the European Medicines Agency
(EMA) has granted a positive opinion recommending approval of DACOGEN®
(decitabine) for Injection. The CHMP is recommending that DACOGEN be
indicated for the treatment of adult patients (age 65 years and above)
with newly diagnosed de novo or secondary acute myeloid leukaemia (AML),
according to the World Health Organisation (WHO) classification, who are
not candidates for standard induction chemotherapy.
The CHMP is the committee responsible for the scientific assessment of
products seeking centralised marketing authorisation throughout the
European Union. The CHMP's positive opinion is now referred for approval
to the European Commission. Janssen anticipates receiving the regulatory
decision from the Commission towards the end of the third quarter of
2012.
The CHMP positive opinion is based on data from the DACO-016 trial, the
largest AML trial to date in this population of older patients. This
randomized, open-label, multi-centre phase 3 clinical trial compared
DACOGEN versus patient's choice with physician's advice of either
supportive care or low-dose cytarabine in patients 65 years and older
with newly diagnosed de novo or secondary acute myeloid leukemia
(AML) and poor- or intermediate-risk cytogenetics. DACOGEN was
administered at 20 mg/m2 as a 1-hour intravenous infusion
once daily for five consecutive days, repeated every four weeks,
continued as long as the patient derived benefit. Key results from this
study were published in the Journal of Clinical Oncology in June
2012.
"Older AML sufferers face very limited options for treatment," commented
Jane Griffiths, Company Group Chairman, Janssen Europe, Middle-East,
Africa. "We are thrilled with today's CHMP announcement and will
continue to work closely with health authorities to make DACOGEN
available to fight this life-threatening illness."