Friday, 19 April 2019

AbbVie provides update on Phase 3 Study of IMBRUVICA

22 January 2019 | News

IMBRUVICA has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as in chronic graft-versus-host-disease for a total of nine FDA-approved indications

AbbVie, a research-based global biopharmaceutical company has announced an update on the Phase 3 RESOLVE trial (PCYC-1137) of ibrutinib (IMBRUVICA®) in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma (cancer).

Metastatic pancreatic cancer is an aggressive and difficult-to-treat solid tumor primarily treated with chemotherapy today. IMBRUVICA is Bruton's tyrosine kinase (BTK) inhibitor jointly developed and commercialized by Pharmacyclics LLC, an AbbVie company, and Janssen Biotech, Inc. (Janssen).

IMBRUVICA has been available in the U.S. since 2013 and is FDA-approved for use in five B-cell blood cancers, as well as in chronic graft-versus-host-disease for a total of nine FDA-approved indications.

PCYC-1137 evaluated the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first-line treatment of patients with metastatic pancreatic cancer.

Danelle James, Head of Clinical Science at Pharmacyclics LLC, an AbbVie company said, "We continue to evaluate the potential of IMBRUVICA as a cancer treatment alone or in combination for a variety of cancer types. We are passionately advancing our robust ibrutinib scientific development program to continue to advance cancer standards of care, particularly in areas that have unmet medical need.”

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses.

PCYC-1137 is a Pharmacyclics, an AbbVie company, sponsored randomized, multicenter, double-blind, placebo-controlled, Phase 3 study of the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib in combination with nab-paclitaxel and gemcitabine versus placebo in combination with nab-paclitaxel and gemcitabine, in the first-line treatment of patients with metastatic pancreatic adenocarcinoma.

 

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