Janssen Pharmaceutical’s IMBRUVICA and Rituximab combo wins FDA approval for waldenström’s macroglobulinemia treatment

Janssen Pharmaceutical, a subsidiary of Johnson & Johnson, has received approval from the US Food and Drug Administration (FDA) for its combination treatment of IMBRUVICA (ibrutinib) and rituximab for Waldenström’s macroglobulinemia (WM), a rare form of blood cancer. This latest approval expands the use of IMBRUVICA in treating WM from monotherapy to now include combination therapy with rituximab, marking it as the first approved non-chemotherapy combination regimen for this disease.

The FDA’s decision to expand the label of IMBRUVICA to include its combination with rituximab provides a significant new treatment option for patients with WM. This is particularly noteworthy as it offers a non-chemotherapy approach, potentially reducing the treatment-related toxicity associated with traditional chemotherapy regimens. The approval is based on the robust results from the phase 3 iNNOVATE study, which evaluated the efficacy and safety of the IMBRUVICA and rituximab combination compared to placebo plus rituximab in 150 patients.

The iNNOVATE study demonstrated that the combination of IMBRUVICA and rituximab significantly improved progression-free survival at 30 months, showcasing superiority over rituximab monotherapy. This combination treatment has shown a substantial advancement in managing both newly diagnosed and relapsed/refractory cases of Waldenström’s macroglobulinemia.

Dr. Lia Palomba, a hematologist-oncologist at Memorial Sloan-Kettering Cancer Center in New York and an iNNOVATE study investigator, highlighted the importance of this new treatment option. “The combination of IMBRUVICA and rituximab provides health care professionals with a new treatment option for patients living with this serious blood cancer,” she stated.

Andree Amelsberg, Vice President of Oncology Medical Affairs at Janssen Scientific Affairs, also commented on the significance of this approval. “The clinical data generated for IMBRUVICA plus rituximab 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,” said Amelsberg.

The FDA approval of the IMBRUVICA and rituximab combination is a transformative step in the treatment landscape for Waldenström’s macroglobulinemia. By providing a non-chemotherapy option, this regimen not only enhances treatment efficacy but also potentially improves the quality of life for patients due to lesser toxicity.