Negative NICE draft guidance for Ninlaro

The National Institute for Health and Care Excellence (NICE) has today issued a negative Appraisal Consultation Document (ACD) for Ninlaro (ixazomib), in combination with lenalidomide and dexamethasone, for the treatment of adults with multiple myeloma who have received at least one prior therapy.

The local subsidiary of Japanese pharma major Takeda Pharmaceutical (TYO: 4502), the drug’s developer, noted that, in November 2016 the European Commission approved ixazomib in this setting based on data from the pivotal Phase III TOURMALINE-MM1 trial, which demonstrated that the all oral triplet combination of ixazomib, lenalidomide and dexamethasone (IRd) increased the length of progression-free survival (when a patient is alive and the disease under control) by around six months, or 35%, when compared with placebo (the doublet combination of Rd).The IRd combination had limited additional toxicity and was well tolerated by patients with no adverse impact on quality of life.

Takeda will persevere to gain approval for Ninlaro