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Ninlaro Approved for Multiple Myeloma
Ixazomib (Ninlaro, Takeda Pharmaceuticals), in combination with two other drugs, has been approved by the FDA to treat people with multiple myeloma who have had at least one prior treatment with a different therapy.
According to HealthDay, multiple myeloma is a type of cancer that forms in infection-fighting white blood cells produced in bone marrow. Symptoms include a weakened immune system and bone and kidney problems.
Ixazomib, from a class of drugs called proteasome inhibitors, is designed to block enzymes that spur the growth and survival of multiple myeloma cells, the FDA said. Almost 27,000 cases of multiple myeloma will be diagnosed in the United States this year, and more than 11,000 people are projected to die from the disease.
The FDA approval of ixazomib is based on results from the TOURMALINE-MM1 phase 3 clinical trial, the first double-blind, placebo-controlled trial with a proteasome inhibitor. TOURMALINE-MM1 is the first of five ongoing phase 3 clinical trials with study results available. The Tourmaline program has enrolled approximately 3,000 patients to date in 40 countries. Data from the trial will be presented at the upcoming 57th Annual Meeting of the American Society of Hematology on December 7, 2015.
TOURMALINE-MM1 is an international, randomized, double-blind, placebo-controlled clinical trial of 722 patients, designed to evaluate ixazomib plus lenalidomide and dexamethasone compared with placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Results showed ixazomib is effective in extending progression-free survival (PFS) and has a manageable safety profile.
The trial achieved its primary endpoint and demonstrated a clinically meaningful and statistically significant prolongation in PFS at this analysis, which showed that patients treated in the ixazomib arm lived without their disease worsening for a significantly longer time compared with patients in the control arm. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes.
In the TOURMALINE-MM1 trial, the most common adverse reactions (20% or more) in patients receiving ixazomib included diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain. Serious adverse reactions reported in at least 2% of patients included thrombocytopenia (2%) and diarrhea (2%).
Efficacy and safety data were reviewed by an Independent Data Monitoring Committee, which recommended the study be continued in blinded fashion to allow further maturation of long-term outcomes, including overall survival and long-term safety.
Ixazomib is the third multiple myeloma drug approved by the FDA this year.
Source: Takeda, November 20, 2015; HealthDay, November 23, 2015.