) submitted a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) for its oncology drug,
Pharmacyclics filed the application on the basis of positive
data from a head-to-head phase III study (RESONATE: n=391) on
Imbruvica as a monotherapy versus
) Arzerra (ofatumumab) for treating patients with chronic
lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL),
who had received at least one prior therapy. Pharmacyclics has a
partnership on Imbruvica with Janssen (a
Johnson & Johnson
According to a planned interim analysis of the randomized,
multicenter, open-label study, conducted in Jan 2014, patients
treated with Imbruvica as a monotherapy exhibited statistically
significant improvement in progression free survival as well as
overall survival compared to those treated with Arzerra alone.
The drug was found to be safe with a favorable benefit risk
profile according to the interim analysis.
We note that the U.S. Food and Drug Administration (FDA)
granted accelerated approval to Imbruvica as a monotherapy for
the above CLL/SLL indication in Feb 2014. Accelerated approval
for the indication was gained on the basis of the overall
response rate (ORR) of patients in a phase Ib/II study which did
not establish improvements in survival or disease-related
symptoms following Imbruvica treatment.
Pharmacyclics also received accelerated approval for Imbruvica
as a monotherapy in the mantle cell lymphoma (MCL) indication
late last year. Approval was gained for treating MCL patients who
have been treated at least once for the disease. Accelerated
approval is granted by the FDA to drugs that are meant to treat
serious conditions and fulfill an unmet medical need based on a
surrogate endpoint. Pharmacyclics is also developing Imbruvica in
other oncology indications.
Pharmacyclics, a biopharmaceutical company, currently carries
a Zacks Rank #2 (Buy). A better-ranked stock in the same sector
). Alkermes holds a Zacks Rank #1 (Strong Buy).
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