Pharmacyclics, Roche Form Clinical Drug Supply Agreement

Pharmacyclics Inc., a biopharmaceutical company, has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability, and preliminary efficacy of Imbruvica (ibrutinib), an oral Bruton’s tyrosine kinase inhibitor, in combination with Gazyva (obinutuzumab), a new CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system, in patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The agreement allows for multiple studies to be considered and conducted. Initially, a Phase III study will be conducted by Pharmacyclics. Plans to evaluate the combination for NHL currently are in development. Imbruvica is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech Inc.

Both products are approved and marketed for the treatment of CLL. Imbruvica is used to treat CLL in patients who have received one prior therapy and in CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment for naive and previously treated del 17p CLL patients. Gazyva is used with the chemotherapy drug, chlorambucil, to treat CLL in patients with previously untreated CLL. The use of these products in combination is investigational only. The study of the investigational combination of Imbruvica and Gazyva through several investigator-sponsored trials also is being considered.  Additional details of the agreement were not disclosed.

Imbruvica is an oral, once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase, a key signaling molecule in the B-cell receptor signaling complex that plays an important role in the survival and spread of malignant B cells. The drug blocks signals that tell malignant B cells to multiply and spread uncontrollably. Imbruvica is approved for the treatment of patients with CLL who have received at least one prior therapy and for the treatment of CLL patients with del 17p, a genetic mutation that occurs when part of chromosome 17 has been lost. The drug is also approved for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.The drug is being studied alone and in combination with other treatments in several blood cancers, including CLL, MCL, Waldenstrom’s macroglobulinemia, diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma. Imbruvica was one of the first medicines to receive US Food and Drug Administration approval via the Breakthrough Therapy Designation pathway and is the only product to have received three Breakthrough Therapy Designations.

Earlier this month, Imbruvica received approval from the European Union for treating relapsed or refractory MCL and CLL. Pharmacylics submitted a supplemental new drug application to the FDA for treating Waldenstrom’s macroglobulinemia, a rare type of B-cell lymphoma.

Source: Pharmacylics.




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