Janssen Pharmaceutical has bagged approval from the US Food and Drug Administration (FDA) for its combo of IMBRUVICA (ibrutinib) and rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare blood cancer.
The FDA approval secured by the Johnson & Johnson subsidiary expands IMBRUVICA’s current label in Waldenström’s macroglobulinemia as a monotherapy to include its combination use with rituximab.
The latest approval from the FDA marks the first approved non-chemotherapy combination regimen for Waldenström’s macroglobulinemia treatment.
For IMBRUVICA, the expanded label for the rare blood cancer is its ninth FDA approval since 2013. The Bruton’s tyrosine kinase (BTK) inhibitor was jointly developed and commercialized by Janssen Biotech and AbbVie’s Pharmacyclics.
Commenting on the approval of IMBRUVICA and rituximab combo for Waldenström’s macroglobulinemia, Dr. Lia Palomba – hematologist-oncologist at Memorial Sloan-Kettering Cancer Center, New York, and iNNOVATE study investigator, said: “The combination of IMBRUVICA and rituximab provides health care professionals with a new treatment option for patients living with this serious blood cancer.
“Before IMBRUVICA, there were no FDA-approved treatment options for patients with Waldenström’s macroglobulinemia, a disease first acknowledged nearly 75 years ago. Today, IMBRUVICA continues to provide an important therapeutic approach in the treatment of this complex disease.”
The FDA approval of IMBRUVICA and rituximab combo for Waldenström’s macroglobulinemia treatment was driven by the results of the phase 3 iNNOVATE study. The late-stage trial assessed IMBRUVICA/rituximab combo against placebo plus rituximab in 150 patients with relapsed/refractory (r/r) disease or previously untreated Waldenström’s macroglobulinemia patients.
According to Janssen Pharmaceutical, the IMBRUVICA rituximab combo delivered significant improvement in progression-free survival at 30 months and achieved superiority versus rituximab monotherapy in Waldenström’s macroglobulinemia.
Andree Amelsberg – Vice President of Oncology Medical Affairs at Janssen Scientific Affairs, commenting on the approval of IMBRUVICA and rituximab combo for the rare blood cancer, said: “The clinical data generated for IMBRUVICA plus rituximab in the treatment of Waldenström’s macroglobulinemia offers physicians evidence to consider this combination regimen for newly-diagnosed patients.
“Today’s approval represents an important milestone for people living with this rare and incurable blood cancer who have limited FDA-approved treatment options.”
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