FDA approves 9th indication for Janssen's Imbruvica
Janssen Pharmaceuticals, of Johnson & Johnson, announced that it has received The Food and Drug Administration’s approval of Imbruvica in combination with rituximab for the treatment of Waldenström’s macroglobulinemia, or WM, a rare blood cancer.
This approval expands the label for Imbruvica in WM beyond its current approved used as a monotherapy to include in combination use with rituximab, the 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," Andree Amelsberg, VP of Oncology Medical Affairs at Janssen Scientific Affairs, said. "We remain dedicated to a comprehensive clinical development program to explore the full potential of Imbruvica, including in combination with other therapies."
The recommended dose of Imbruvica is 420 mg orally once daily. The drug is indicated to treat adults with chronic lymphotic leukemia, small lymphotic lymphoma, chronic lymphotic leukemia, small lymphotic lymphoma with 17p deletion, mantle cell lymphoma, marginal zone lymphoma and chronic graft-versus-host disease.
Further information on the product, including warning and safety information can be found on the company’s website.
This approval expands the label for Imbruvica in WM beyond its current approved used as a monotherapy to include in combination use with rituximab, the 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," Andree Amelsberg, VP of Oncology Medical Affairs at Janssen Scientific Affairs, said. "We remain dedicated to a comprehensive clinical development program to explore the full potential of Imbruvica, including in combination with other therapies."
The recommended dose of Imbruvica is 420 mg orally once daily. The drug is indicated to treat adults with chronic lymphotic leukemia, small lymphotic lymphoma, chronic lymphotic leukemia, small lymphotic lymphoma with 17p deletion, mantle cell lymphoma, marginal zone lymphoma and chronic graft-versus-host disease.
Further information on the product, including warning and safety information can be found on the company’s website.