European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the conditional approval of Takeda Pharmaceutical's NINLAROTM (ixazomib) capsules in combination with lenalidomide and dexamethasone, for the treatment of adult patients suffering with multiple myeloma who have received at least one therapy.
Multiple myeloma is a cancer of the plasma cells located in the bone marrow.
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Once the European Commission ratifies the CHMP’s opinion and authorisation is granted, NINLARO will become the first and only oral proteasome inhibitor approved for use across the European Economic Area, which comprises the 28 member states of the EU in addition to Norway, Liechtenstein and Iceland.
Takeda Oncology president Christophe Bianchi said: “The positive CHMP opinion for the conditional approval of NINLARO is an important first step to bringing this treatment to a relapsed and / or refractory patient population where there is a significant unmet need.”
“Currently approved proteasome inhibitors are only available through twice-weekly injections and infusions, which can place additional logistical burdens on patients and their caregivers, who already are dealing with a difficult disease.
"We hope that the efficacy, convenience and manageable safety profile of this innovative treatment may allow for extended duration of treatment, which has the potential to improve patient outcomes.
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By GlobalData"Thank you to the patients and investigators for their participation in the TOURMALINE-MM1 trial to further our understanding of NINLARO’s benefits.”
To receive conditional approval, Takeda has to offer post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other ongoing studies to show the treatment's long-term effects.
NINLARO secured its first approval from the US Food and Drug Administration in November 2015 after priority review.
In the US it is indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
NINLARO is presently licensed for use in the US, Canada, Israel and Venezuela and is additionally under review for approval by a number of regulatory authorities worldwide.
Following the CHMP’s positive opinion for the conditional approval of NINLARO, it will now be reviewed by the European Commission.
