Takeda Pharmaceutical Company Limited Announces FDA Approval of NINLARO for Multiple Myeloma Treatment

Strategic Insights -

The U.S. Food and Drug Administration (FDA) has approved NINLARO, a once-weekly oral proteasome inhibitor, for the treatment of patients with multiple myeloma who have received at least one prior therapy. This approval marks a significant milestone in the treatment of multiple myeloma, a devastating and incurable rare cancer. The approval of NINLARO is based on results from the TOURMALINE-MM1 Phase 3 clinical trial, which demonstrated the efficacy and safety of NINLARO in combination with lenalidomide and dexamethasone.

Key Takeaways:

  • NINLARO is the first and only oral proteasome inhibitor approved by the FDA for the treatment of patients with multiple myeloma who have received at least one prior therapy.
  • The TOURMALINE-MM1 Phase 3 clinical trial demonstrated the efficacy and safety of NINLARO in combination with lenalidomide and dexamethasone, showing a statistically significant prolongation in Progression Free Survival (PFS).
  • The most common adverse reactions in patients receiving NINLARO included diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.
  • Serious adverse reactions reported in 2% or more patients included thrombocytopenia (2%) and diarrhea (2%).
  • NINLARO is administered orally, once-weekly on days 1, 8, and 15 of a 28-day treatment cycle.
  • The company plans to introduce and expand access to NINLARO in other markets around the world.
  • The FDA approval of NINLARO is based on results from the TOURMALINE-MM1 Phase 3 clinical trial, which included 22% of patients with renal impairment and 22% with light chain disease.

Statistics:

  • 722 patients were enrolled in the TOURMALINE-MM1 trial.
  • The trial achieved its primary endpoint and demonstrated a clinically meaningful and statistically significant prolongation in PFS.
  • 22% of patients in the NINLARO arm had renal impairment, and 22% had light chain disease.
  • 2% or more patients experienced serious adverse reactions, including thrombocytopenia (2%) and diarrhea (2%).

Sources:

  • Takeda Pharmaceutical Company Limited. News Release. Takeda's NINLARO (ixazomib) capsules, the first and only oral proteasome inhibitor, approved by the FDA for the treatment of patients with multiple myeloma who have received at least one prior therapy. Business Wire. 2015.
  • Business Wire. Takeda's NINLARO (ixazomib) capsules, the first and only oral proteasome inhibitor, approved by the FDA for the treatment of patients with multiple myeloma who have received at least one prior therapy. Business Wire. 2015.
  • Takeda Pharmaceutical Company Limited. NINLARO (ixazomib) capsules. Product Information. 2015.
  • NewsRx. Takeda Pharmaceutical Company Limited Announces FDA Approval of NINLARO for Multiple Myeloma Treatment. NewsRx. 2015.