History

Moments in Time

2018

In March, a new single-tablet formulation of ibrutinib was introduced as an innovation for patients with a one pill, once-a-day dosing regimen. This new formulation was developed with the intention of improving daily adherence, available in four dosing strengths (560, 420, 280, and 140 mg tablets), in addition to the existing 140 mg capsule formulation.

In August, the FDA approved ibrutinib plus rituximab as the first chemotherapy-free treatment for adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL).

2017

In January, the FDA granted ibrutinib accelerated approval for the treatment of adult patients with Marginal Zone Lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.*

In August, the FDA approved ibrutinib for the treatment of adult patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

*Accelerated approval was granted for this indication based on overall response rate. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials.

2016

In March, the FDA approved ibrutinib for first-line treatment of adult patients with Chronic Lymphocytic Leukemia (CLL).

In May, the FDA expanded the ibrutinib label to include first-line treatment for Small Lymphocytic Lymphoma (SLL) adult patients.

2015

In January, the FDA approved ibrutinib for the treatment of adult patients with Waldenström’s Macroglobulinemia (WM) in all lines of therapy.

In May, AbbVie acquired Pharmacyclics.

Ibrutinib receives the 2015 Prix Galien award for Best Pharmaceutical Agent.

2014

In February, the FDA approved ibrutinib for the treatment of Chronic Lymphocytic Leukemia (CLL) for adult patients who have received at least one prior therapy.

In July, the FDA extended ibrutinib's approval to treat CLL adult patients with 17p deletion.

2013

In November, the FDA granted ibrutinib accelerated approval for the treatment of adult Mantle Cell Lymphoma (MCL) patients who have received at least one prior therapy.*

*Accelerated approval was granted for this indication based on overall response rate. Continued approval for these indications may be contingent upon verification of clinical benefit in confirmatory trials.

2012

Pharmacyclics presented data at American Society of Hematology congress showing prolonged duration of response in Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL) data from Phase 2 clinical trials, which were later published in the New England Journal of Medicine.

2011

In December, Pharmacyclics entered into an agreement with Janssen Biotech, Inc. (a Johnson & Johnson Company) to develop and commercialize ibrutinib for hematological cancers.

2010

Pharmacyclics presented proof of concept data for ibrutinib at the Annual Society of Hematology Congress (ASH) in a variety of B-cell malignancies, along with promising data from several Phase 1b/2 studies.

2009

Pharmacyclics initiated the first-in-human Phase 1 clinical trial of ibrutinib.

2006

Pharmacyclics licensed the BTK (Bruton’s tyrosine kinase) Inhibitor Program, focusing its research and development on PCI-32765, the BTK inhibitor ibrutinib.

1991

Pharmacyclics was founded by Dr. Jonathan Sessler and Dr. Richard Miller, to develop a new therapeutic approach to treat cancer patients with unmet medical needs.