Takeda Pharmaceutical Company Limited has announced that Ninlaro (ixazomib) capsules, the first and only oral proteasome inhibitor, are now available in the United States. Ninlaro is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Takeda recently received US Food and Drug Administration (FDA) approval for Ninlaro, four months prior to its Priority Review PDUFA date. Ninlaro is a once-weekly pill for three weeks of a four week cycle.
“With NINLARO now available in the US, we have taken our extensive research and turned it into a reality. In addition to the clinical investigators and patients, I would like to extend our thanks to the FDA for its expedited review of Ninlaro. The need for new and differentiated treatment options is urgent, and their commitment allowed us to bring Ninlaro to market within a rapid timeframe,” said Christophe Bianchi, M.D., president, Takeda Oncology.
“In the short time since receiving FDA approval of Ninlaro, we have seen an enthusiastic reception from providers and patients alike; in fact, prescriptions have already been written by physicians and approved by insurers. We are excited to realise our commitment to the multiple myeloma community as we bring Ninlaro to patients.”
Ninlaro is a pill that can be taken at home which may reduce some of the logistical burden for patients, because administration does not require an infusion or injection at a hospital, clinic or physician’s office. For patients prescribed Ninlaro, Takeda is offering Ninlaro 1Point, a comprehensive support programme offering an array of access and coverage services.
“Access to therapy for patients in need is our first and foremost priority,” said Ryan Cohlhepp, vice president of US marketing at Takeda.
“And with Ninlaro 1Point, we have created a robust suite of support services to help patients access Ninlaro.”
Ninlaro is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). Ninlaro also received Breakthrough Therapy status by the US FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.
The TOURMALINE clinical development programme 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.
In addition to the TOURMALINE programme, a large number of investigator initiated studies are evaluating ixazomib for patients globally.
The most common adverse reactions occurring in greater than or equal to 20 per cent of patients treated with Ninlaro were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.
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 red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with more than 26,000 new cases in the US and 114,000 new cases globally per year.