NICE backs consolidation use of Blincyto in leukaemia

Sales of Amgen's Blincyto have grown slowly since it was first introduced a decade ago, but have started to gather momentum thanks to expanded use in acute lymphoblastic leukaemia (ALL), which will now extend to NHS patients in England.

Health technology assessment (HTA) agency NICE has just backed the use of Blincyto (blinatumomab) plus chemotherapy for consolidation treatment of Philadelphia chromosome-negative, CD19-positive B-cell precursor ALL in adults, provided no detectable cancer cells are left in the body after treatment – in other words, they are negative for minimal residual disease (MRD).

The new use unlocks a new patient population for Blincyto, which was the first bispecific T-cell engager (BiTE) drug to be approved for marketing in 2014 for precursor B-cell ALL, but until now has been limited to treating patients with MRD after induction treatment. Consolidation is a phase of frontline treatment for ALL patients, which takes place after the induction phase.

Blincyto's label has gradually been extended since 2014, and in December the MHRA approved it as the first immunotherapy for consolidation use in these patients on the strength of the E1910 clinical trial, which showed an improvement in overall survival with the drug when it was added to standard of care consolidation chemotherapy.

After a median follow-up of 4.5 years, the blinatumomab treatment group showed a significantly improved OS, with a 56% reduction in the risk of death.

In general, patients who are MRD-negative have a better prognosis than patients who are MRD-positive, but they are still at risk of relapse and Blincyto has been held up as a new standard of care in this setting.

In a statement, NICE said that around 80 patients per year could benefit from the new combination treatment that "creates a breakthrough in the way the immune system fights cancer cells."

Blincyto funding will be made available immediately by NHS England, it continued, adding that the decision to cover the drug stems in part from patient expert testimony that up to 50% of patients relapse, despite seeing a complete response to induction treatment.

"The experiences shared by patients were invaluable in helping us understand just how much impact this treatment could have on people's lives," said Helen Knight, director of medicines evaluation at NICE.

"This treatment could give patients precious extra months and potentially years with their loved ones," she added. "The evidence showing how well it works is really compelling."

Sales of Blincyto have risen sharply on the back of the new indication, which was approved in the US last year and in the EU earlier this month. Sales last year rose 41% to more than $1.2 billion, taking it into blockbuster territory for the first time.