CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that a New Drug Application (NDA) has been submitted to the United States (U.S.) Food and Drug Administration (FDA) for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.
The NDA submission was based on the pivotal Phase 3 trial TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial of 722 patients 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. Patients continue to be treated in this trial and evaluated for long-term outcomes.
“The TOURMALINE-MM1 study is the first in a series of five Phase 3 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,” said Andrew Plump, M.D., Ph.D., Takeda’s Chief Medical and Scientific Officer. “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.”
“Continuous treatment is emerging as a standard of care in multiple myeloma with demonstrable improvement in long-term outcomes,” commented Paul Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center, Institute Physician at Dana-Farber Cancer Institute. “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.”
This is the first regulatory submission for ixazomib. Additional filings are planned to begin in Europe and other countries later this year.
About Multiple Myeloma
Multiple myeloma is a cancer of the
plasma cells, which are found in the bone marrow. In multiple myeloma, a
group of plasma cells, or myeloma cells, becomes cancerous and
multiplies, increasing the number of plasma cells to a higher than
normal level. Because plasma cells circulate widely in the body, they
have the potential to affect many bones in the body, possibly resulting
in compression fractures, lytic bone lesions and related pain. Multiple
myeloma can cause a number of serious health problems affecting the
bones, immune system, kidneys and an individual’s red blood cell count,
with some of the more common symptoms including bone pain and fatigue, a
sign of anemia. Multiple myeloma is a rare form of cancer with
approximately 20,000 new cases in the U.S. and 114,000 new cases
globally per year.
About Ixazomib
Ixazomib (MLN9708) is an investigational oral
proteasome inhibitor which is being studied in multiple myeloma, AL
amyloidosis, and other malignancies. Ixazomib was granted orphan drug
designation in multiple myeloma in both the U.S. and Europe in 2011 and
for AL amyloidosis in both the U.S. and Europe in 2012. Ixazomib
received Breakthrough Therapy status by the U.S. Food and Drug
Administration (FDA) for relapsed or refractory AL amyloidosis in 2014.
It is also the first oral proteasome inhibitor to enter Phase 3 clinical
trials.
Ixazomib’s clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:
- TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma
- TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma
- TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)
- TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT
- TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis
For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov.
About Takeda Oncology
Takeda Oncology is a global business
unit of Millennium Pharmaceuticals Inc., a wholly owned subsidiary of
Takeda Pharmaceutical Company Limited. Takeda aspires to cure cancer by
delivering novel medicines to meet the unique and urgent needs of people
living with cancer, their loved ones and the health care providers who
support them around the world. Takeda is the 11th largest
global oncology company with a portfolio of paradigm-changing therapies
and an extensive pipeline of investigational products that have the
potential to significantly improve patient outcomes across a number of
cancers. By combining the power of leading scientific minds with our
agile and entrepreneurial spirit and the vast resources of a global
pharmaceutical company, Takeda Oncology is finding new and innovative
ways to improve the treatment of cancer. Additional information about
Takeda Oncology is available through its website, www.takedaoncology.com.
About Takeda
Located in Osaka, Japan, Takeda is a
research-based global company with its main focus on pharmaceuticals. As
the largest pharmaceutical company in Japan and one of the global
leaders of the industry, Takeda is committed to strive towards better
health for people worldwide through leading innovation in medicine.
Additional information about Takeda is available through its corporate
website, www.takeda.com.
