FDA approves 3rd multiple myeloma med of 2015, Takeda's Ninlaro
- The FDA approved Ninlaro (ixazomib) on Friday, making it the first approved oral proteasome inhibitor. It is intended to be used in combination with Revlimid (lenolidamide) and dexamethasone for second-line treatment of multiple myeloma.
- According to the National Cancer Institute, there will be a total of 26,850 new cases of multiple myeloma in 2015 and 11,240 related deaths.
- Ninlaro is the third drug for multiple myeloma approved this year.
What a year it's been for innovation in the treatment of multiple myeloma: 3 new drugs approved and the year is not even over. First, the FDA gave Novartis’ Farydak (panobinostat) a green light in February, followed by Darzalex (daratumumab) from Johnson & Johnson and Genmab. Notably, each of these drugs advances care by either adding another treatment option or by improving convenience and ease of use.
The approval is based on the strength of data from a phase 3 clinical trial involving 722 patients with multiple myeloma who had failed a previous treatment. Patients receiving the approved combination therapy regimen with Ninlaro were compared with those who only took Revlimid (lenolidamide) and dexamethasone.
Overall, patients taking the Ninlaro-based regimen experienced 20.6 months of progression-free survival (PFS), compared with a PFS of 14.7 months for those treated with Revlimid and dexamethasone only. That was enough of a difference to justify an approval.