Pharmacyclics LLC, an AbbVie company, and Janssen Biotech Inc., developers of the award-winning drug Imbruvica (ibrutinib), aim to continue enhancing the cancer-fighting drug’s clinical meaningfulness.
“We have an ambitious, but achievable goal of securing one to two additional approvals for Imbruvica annually over the next several years," AbbVie spokeswoman Erica Jefferson told American Pharmacy News. "We currently have one of the most robust clinical oncology development programs for a single molecule in the industry with nearly 30 company-sponsored trials underway."
In addition, Jefferson said there are 44 investigator-sponsored trials taking place around the world.
Imbruvica is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for use in individuals with chronic lymphocytic leukemia (CLL) who have received at least one prior treatment; those with CCL who carry a deletion in chromosome 17; patients who have been previously treated for mantle cell lymphoma (MCL); and people with Waldenstrom macroglobulinemia (WM), which is a type of non-Hodgkin's lymphoma. The drug interferes with the function of Bruton's tyrosine kinase (BTK) and blocks signals that would otherwise allow the growth of cancerous B cells.
In addition to blood cancers such as follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM) and marginal zone lymphoma (MZL), the oral therapy also is being investigated in difficult-to-treat immune-mediated diseases such as chronic Graft-versus-Host Disease (GvHD), a disease with limited treatment options, Jefferson said.
“The early results we’ve seen in Imbruvica-treated chronic GvHD patients have been very encouraging,” she said.
At the same time, Imbruvica is being studied in combination with other novel investigational agents (such as checkpoint inhibitors) in solid tumor cancers, such as breast, pancreatic and lung, Jefferson added.
“Ultimately, our goal is for Imbruvica to become a backbone of therapy in hematological cancer care, with the potential for even broader usage to advance patient care in the future,” she said.
Most recently, Imbruvica received the 2015 Prix Galien Award for Best Pharmaceutical Agent, considered the highest accolade in the biomedical industry. The award honors excellence in biopharmaceutical research and development aimed at improving the human condition.
“Receiving the Prix Galien Award ... for Imbruvica was a tremendous honor for both Janssen and Pharmacyclics," Jefferson said. "We were proud to bring this transformative therapy to patients living with certain hematologic disorders in record time."
Of note, she added, is that in 2015 the developers initiated their first Phase 3 clinical trial investigating Imbruvica in combination with paclitaxel and gemcitabine in first-line patients with metastatic pancreatic adenocarcinoma. Jefferson said that the trial is currently enrolling.
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