Pharmacyclics, Inc.
PCYC today announced that it has entered into a master clinical
drug supply agreement with Roche RORHHBY to evaluate
the safety, tolerability and preliminary efficacy of IMBRUVICA(R)
(ibrutinib), an oral Bruton's tyrosine kinase (BTK) inhibitor, in
combination with GAZYVA(R) (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 3 study will be conducted by Pharmacyclics in CLL/SLL. 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 naive and previously treated del 17p CLL patients.
GAZYVA is used with the chemotherapy drug, chlorambucil, to treat CLL in
patients with previously untreated chronic lymphocytic leukemia. The use of
these products in combination is investigational only.
"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 & CEO, 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."
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.
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