Nov 1 U.S. regulators on Friday approved Roche
Holding AG's new drug for patients with chronic
lymphocytic leukemia (CLL) who have not previously been treated
for one of the most common forms of blood cancer.
The U.S. Food and Drug Administration said the new drug,
Gazyva (obinutuzumab), works by helping certain immune system
cells to attack cancer cells, and is meant to be used with a
standard chemotherapy treatment for the disease called
It is the first drug to be approved by the FDA after
receiving its "breakthrough therapy" designation, the agency
said. The new designation indicates the medicine may offer
substantial improvement over current treatments for patients
with serious or life-threatening diseases.
Roche in July presented initial data from a late-stage trial
that showed Gazyva, previously known as GA101, delayed disease
progression in patients with CLL longer than its top-seller
Rituxan. Detailed data demonstrating the magnitude of the
improvement over Rituxan is expected to be presented at the
American Society of Hematology annual meeting in December.
The Swiss drugmaker's $7 billion-a-year Rituxan loses
European patent protection late this year, although it is not
known when cheaper generic, or biosimilar, forms of the drug
will be allowed on the market.
In the meantime, Roche hopes to switch as many patients as
possible to Gazyva from Rituxan prior to the introduction of
cheaper biosimilar versions of the older drug. Rituxan, also
known as MabThera, is an antibody against white blood cells that
have the so-called CD20 protein on their surface. It is used to
treat lymphomas, leukemias, transplant rejection and rheumatoid
Gazyva was designed to be more potent than Rituxan in
attacking such white blood cells, known as B cells, from which
many blood cancers, such as CLL and lymphomas, originate.
Gazyva will carry a prominent "black-box" warning on its
package insert label, noting that it can reactivate Hepatitis B
infections and can cause a rare brain infection called
progressive multifocal leukoencephalopathy. PML, which can be
fatal, has also been seen as a rare side effect associated with
long-term use of some multiple sclerosis treatments.
Roche's Genentech unit said Gazyva will become available in
the United States in about two weeks and is still awaiting
approval in Europe and other markets.
The FDA said more than 15,000 Americans will be diagnosed
with chronic lymphocytic leukemia this year, and almost 5,000
will die from the disease.
Roche shares were up 0.8 percent in Switzerland.