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news.Japan-based Takeda Pharmaceutical Company has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for ixazomib, an investigational oral proteasome inhibitor, to treat patients with relapsed and/or refractory multiple myeloma.
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The NDA was based on the pivotal international, randomized, double-blind, placebo controlled Phase III trial (TOURMALINE-MM1).
Around 722 patients were included in the trial, which is designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.
The company noted that patients continue to be treated in this trial and evaluated for long-term outcomes.
Takeda chief medical and scientific officer Andrew Plump said: "The TOURMALINE-MM1 study is the first in a series of five Phase III trials within our ixazomib program, which is designed to evaluate whether sustained therapy with a proteasome inhibitor, delivered orally, improves the clinical outcomes of patients living with multiple myeloma or with systemic light-chain (AL) amyloidosis.
"This submission marks an important step in Takeda’s ongoing commitment to innovation for patients living with multiple myeloma. We thank the patients and their families for placing their trust in us and in ixazomib as they continue to participate in the TOURMALINE program."
This is the first regulatory submission for ixazomib and additional filings are scheduled to start in Europe and other countries later this year.
Dana-Farber Cancer Institute Clinical Research director Paul Richardson said: "Continuous treatment is emerging as a standard of care in multiple myeloma with demonstrable improvement in long-term outcomes.
"Proteasome inhibition has become an essential component of treatment, but there are logistical challenges for patients with both intravenous and subcutaneous approaches, and especially in the absence of an effective oral option.
"If approved, ixazomib, with the convenience of once-a-week oral administration as well as promising efficacy, should provide a very meaningful advance for our patients."
Currently, Ixazomib is being studied in multiple myeloma, AL amyloidosis and other malignancies.
The drug was granted orphan drug designation in multiple myeloma in both the US and Europe in 2011 and for AL amyloidosis in both the US and Europe in 2012.
Last year, the US Food and Drug Administration (FDA) has granted breakthrough therapy status for Ixazomib to treat relapsed or refractory AL amyloidosis.
Image: Takeda Midosuji Building, the head office of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o.