10.20.14
Pharmacyclics, Inc. has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and efficacy of IMBRUVICA (ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in combination with GAZYVA (obinutuzumab), a new CD20-directed antibody in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Pharmacyclics will initially conduct a Phase III study in CLL/SLL, and plans to evaluate the combination for NHL. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Both products are approved for the treatment of CLL. The use of these products in combination is investigational.
"We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, chairman and chief executive officer, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL."
Pharmacyclics will initially conduct a Phase III study in CLL/SLL, and plans to evaluate the combination for NHL. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc. Both products are approved for the treatment of CLL. The use of these products in combination is investigational.
"We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, chairman and chief executive officer, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL."