IBRUTINIB HAS BEEN APPROVED IN CLL
IBRUTINIB HAS BEEN APPROVED IN CLL
IBRUTINIB HAS BEEN APPROVED IN CLL
IBRUTINIB HAS BEEN APPROVED IN CLL
IBRUTINIB HAS BEEN APPROVED IN CLL
IBRUTINIB HAS BEEN APPROVED IN CLL
Here is the press release from ASCO:
From
the American Society of Clinical Oncology
In cooperation with the
Food and Drug Administration (FDA), and as a service to our members, ASCO will
periodically distribute information about newly approved therapies for cancer
patients. This helps FDA to inform oncologists and professionals in
oncology-related fields of recent approvals in a timely manner. Included
in the email from the FDA will be a link to the product label, which will
provide the relevant clinical information on the indication, contraindications,
dosing, and safety. In sending this information, ASCO does not endorse
any product or therapy and does not take any position on the safety or efficacy
of the product or therapy described. The following is a message from the
FDA's Office of Hematology and Oncology Products Director, Dr. Richard Pazdur:
On February
12, 2014, the U. S. Food and Drug Administration granted accelerated approval
to ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) for the treatment of patients
with chronic lymphocytic leukemia (CLL) who have received at least one prior
therapy. Ibrutinib previously received accelerated approval on November
13, 2013 for the treatment of patients with mantle cell lymphoma who have
received at least one prior therapy.
The approval
in CLL was based on the results of a multi-center, single-arm trial of 48
patients with previously treated CLL. The median age was 67 years (range, 37 to
82 years) and 71% were male. All patients had a baseline ECOG performance
status of 0 or 1. The median time since diagnosis was 6.7 years and the median
number of prior treatments was 4 (range, 1 to 12 treatments). Ibrutinib
was administered orally at 420 mg once daily until disease progression or
unacceptable toxicity.
The efficacy
results demonstrated a 58.3% overall response rate (95% CI: 43.2, 72.4) as assessed
by an independent review committee. No complete responses were observed.
The response duration ranged from 5.6 to 24.2+ months; the median was not
reached.
The safety
profile of ibrutinib for patients with previously treated CLL was consistent
with observations in the mantle cell lymphoma clinical trial. The most
common adverse reactions reported in the CLL clinical trial (occurring in
greater than or equal to 20% of patients) were thrombocytopenia, diarrhea,
bruising, neutropenia, anemia, upper respiratory tract infection, fatigue,
musculoskeletal pain, rash, pyrexia, constipation, peripheral edema,
arthralgia, nausea, stomatitis, sinusitis, and dizziness.
As a
condition of this accelerated approval, the FDA required that the sponsor
submit results of randomized clinical trial(s.) In January 2014, Pharmacyclics
notified FDA of the early stopping of the RESONATE trial by the Data Monitoring
Committee (DMC) based on favorable results of a planned interim analysis.
RESONATE, a phase 3 clinical trial, randomized patients to either ibrutinib or
ofatumumab. Patients entered on this trial had previously treated CLL or
small lymphocytic lymphoma (SLL) and were not considered candidates for
treatment with purine analogue-based treatments. The trial was reported
to demonstrate an improvement in progression-free survival and overall
survival.
The
recommended dose and schedule of ibrutinib for patients with CLL is 420 mg
(three 140 mg capsules) taken orally once daily.
Full prescribing information is available
at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203147s000lbl.pdf