(Adds comment by regulator, analyst forecast, background, stock
Feb 12 U.S. health regulators on Wednesday
approved the Johnson & Johnson and Pharmacyclics Inc
cancer drug Imbruvica to treat chronic lymphocytic
leukemia, a slowly progressing form of blood cancer.
The Food and Drug Administration decision marks the second
approval recently for the oral medicine, known chemically as
ibrutinib. In November, the drug won U.S. approval to treat a
rare and aggressive form of non-Hodgkin lymphoma called mantle
cell lymphoma in patients who have received prior treatment with
at least one other therapy.
The latest approval is also for so-called second line
therapy after at least one prior treatment fails or stops
working, the FDA said.
"Today's approval provides an important new treatment option
for CLL patients whose cancer has progressed despite having
undergone previous therapy," Richard Pazdur, head of the FDA's
Office of Hematology and Oncology Products, said in a statement.
"The FDA completed its review of Imbruvica's new indication
under the agency's accelerated approval process, which played a
vital role in rapidly making this new therapy available to those
who need it most," Pazdur said.
About 15,680 Americans were diagnosed with CLL and 4,580
died from the disease in 2013, according to the National Cancer
There had been some disappointment in the market when the
original approval of the drug did not include both types of
cancer. The second approval provided a jolt for Pharmacyclics
shares, which were up 6.7 percent at $141.75 on the Nasdaq on
RBC Capital Markets analyst Michael Yee has been
forecasting long-term annual worldwide sales of $5 billion for
According to long-term follow-up data from a midstage
clinical trial presented at a major medical meeting in December,
the drug maintained its effectiveness in keeping the disease at
bay for most patients.
With a median follow-up of more than 27 months of treatment,
nearly all of the previously untreated patients and almost
three-quarters of the relapsed patients in the study had no
evidence of their CLL progressing.
"Patients receiving ibrutinib are doing much better than
historically what we're used to seeing with CLL," Dr John Byrd,
a co-leader of that study, told Reuters at the time.
While Pharmacyclics shares were up sharply, shares of the
far larger J&J were off 0.5 percent at $92.51 on the New York
(Reporting by Bill Berkrot in New York; editing by Andre Grenon
and Matthew Lewis)