Leukaemia drugs move closer to European approval

Two groundbreaking new treatments for chronic lymphocytic leukaemia have been recommended by Europe’s CHMP medicines committee.

This means the two drugs, Janssen’s Imbruvica (ibrutinib) Gilead’s Zydelig (idelalisib) are just one step away from final approval from European regulator the EMA.

Imbruvica and Zydelig are recommended to treat adult patients with chronic lymphocytic leukaemia who have received at least one prior treatment, as well as a first-line treatment for patients with a specific genetic mutation that makes them unsuitable for chemo-immunotherapy.

Imbruvica is an orphan medicine, and is also recommended to treat adult patients with mantle cell lymphoma that has come back after previous treatments or is not responding to other treatments. Zydelig will also be used for adult patients with follicular lymphoma that has not responded to two previous treatments.

The news coincides with an announcement that Imbruvica has received full marketing approval from the FDA – confirming its safety and efficacy after being fast-tracked via the FDA’s Breakthrough Therapy Designation route.

The full approval applies to two indications: treating patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients.

Analysts GlobalData forecasts that Imbruvica and Zydelig will have total combined sales of $2 billion in 2018, thus capturing more than 60% of the total CLL market by the end of the forecast period.

As with many new cancer treatments, the pricing of the drugs will be closely watched by healthcare systems across Europe, as the treatments will not only raise the cost of treating existing patients, but potentially expand the numbers treated.

Diabetes combination

Meanwhile, among the other European regulatory decisions, Novo Nordisk has received a CHMP approval for its diabetes combination treatment Xultophy.

The drug is the first once-daily single injection combination of Tresiba (insulin degludec) and Victoza (liraglutide) and will be indicated for adults with type 2 diabetes in combination with oral glucose-lowering treatments when these alone or combined with basal insulin do not provide adequate glycaemic control.


Gilead’s leukaemia drug Zydelig gains US approval

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