Johnson & Johnson‘s (NYSE:JNJ) Janssen division said today that it won new FDA approval for its Imbruvica, clearing it for use in treating the rare blood cancer Waldenström’s macroglobulinemia in combination with ritumixab.
The approval expands the label for Imbruvica to include combination use with ritumixab, and represents “the first approved non-chemotherapy combination option for the treatment of WB,” the Horsham, Penn.-based company 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. We remain dedicated to a comprehensive clinical development program to explore the full potential of Imbruvica, including in combination with other therapies,” Janssen Scientific Affairs oncology medical affairs VP Dr. Andree Amelsberg said in prepared remarks.
The drug first won approval as a singular therapy for WM in January 2015 through a breakthrough therapy designation pathway with the FDA, making it the first approved therapy for the disease, Janssen said.
Approval came based off results from the Innovate study which evaluated the drugs in combination versus a placebo paired with rituximab in 150 patients with WM. Results at a median follow up at 26.5 months indicated a higher rate of progression-free survival at 82% with the combined therapy versus 28% in the placebo group and that patients receiving the combined drugs had an 80% reduction in relative risk of disease progression or death, the company 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,” Innovate study investigator Dr. Lia Palomba of New York’s Memorial Sloan-Kettering Cancer Center said in a press release.
“Results from Innovate showed significant improvement in progression-free survival at 30 months and demonstrated the superiority of Imbruvica plus rituximab over rituximab monotherapy in Waldenström’s macroglobulinemia. Based on these results, Imbruvica in combination with rituximab may be considered as a first- and second-line option for appropriate people diagnosed and living with WM,” Innovate lead study investigator Dr. Meletios Dimopoulos of Greece’s Kapodistrian University of Athens School of Medicine said in a prepared statement.