Top 5 things to know about new myeloma drug

November 23, 2015

In FDA’s latest approval of a new medication to treat multiple myeloma, the agency approved Ninlaro capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy

In FDA’s latest approval of a new medication to treat multiple myeloma, the agency said last week that it approved Ninlaro (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.

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FDA also recently approved Janssen Biotech’s daratumumab (Darzalex) injection for intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy.

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Here are the top 5 things to know about Ninlaro:

  • Ninlaro is a unique multiple myeloma treatment, since it is available in pill form. “Ninlaro’s oral administration may help reduce the logistical burdens many multiple myeloma patients face with other therapies that require an infusion or injection,” Christophe Bianchi, MD, president of Takeda Oncology, told FormularyWatch. “We recognize there is a need for simple, safe and sustainable therapies for patients with multiple myeloma. We also want to help address the quality of life factors that impact patients every day."

  • Each Ninlaro 28-day cycle of treatment is list priced at $8,670, similar to the monthly cost of Velcade. “Velcade has consistently been viewed by independent bodies – such as ASCO, Memorial Sloan Kettering Cancer Center and the NCCN – as a drug with great value. We aspire to continue this value proposition with Ninlaro,” according to a statement from Takeda Oncology provided to FormularyWatch. “While we are confident in the value Ninlaro brings, we have not priced the drug at a premium.”

  • Takeda Pharmaceuticals submitted a New Drug Application for Ninlaro to FDA in July 2015, and in September, Ninlaro was granted Priority Review status with a PDUFA date of March 10, 2016.

  • FDA’s approval of Ninlaro is based on results from the TOURMALINE-MM1 phase 3 clinical trial, the first double-blind, placebo-controlled trial with a proteasome inhibitor. The TOURMALINE program has enrolled approximately 3,000 patients in 40 countries. “We, as investigators of the TOURMALINE-MM1 trial, felt it was vital to conduct a comprehensive ‘real-world’ evaluation of this combination that included some of the most common patient types in the relapsed/refractory multiple myeloma setting, such as older patients, patients with moderate renal impairment, light chain disease, and high-risk cytogenetics,” Paul Richardson, MD, clinical program leader and director of clinical research at the Jerome Lipper Multiple Myeloma Center Institute, physician at Dana-Farber Cancer Institute, and investigator for TOURMALINE-MM1. “Further, we treated patients until disease progression to determine the sustainability of Ninlaro in treating their relapsed/refractory disease. The TOURMALINE-MM1 data demonstrate convincingly that oral NINLARO-based triplet treatment is effective at extending progression-free survival, over and above the clinical benefit seen with lenalidomide and dexamethasone, with a tolerable safety profile.”

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