* FDA pertuzumab U.S. approval decision due by June 8
* Drug is used with Herceptin in HER2-positive patients
* Roche shares up 1.9 percent
Feb 7 U.S. health regulators granted a
priority review for an experimental Roche breast cancer
drug that in clinical trials added six months to the time before
the disease worsened.
The Food and Drug Administration will make its decision on
whether to approve pertuzumab by June 8, Roche Holding AG's
Genentech unit said on Tuesday.
With priority review status, the FDA decides whether to
approve a drug within six months, rather than the usual 10- to
12-month review period. The agency grants priority review to
medicines that are considered potentially significant
therapeutic advancements over existing therapies.--
Analysts on average have forecast annual pertuzumab sales of
$274 million by 2015, according to Thomson Reuters.
In a pivotal clinical trial, patients who received
pertuzumab in combination with Herceptin - another Roche breast
cancer drug - and a chemotherapy agent lived for an average of
18.5 months without their tumors growing. That compared with
12.4 months for those who got only Herceptin and the chemo drug.
Overall survival data from that trial is not expected to be
available until 2013, but the FDA apparently found the available
progression-free survival data compelling enough to makes its
decision prior to that.
Pertuzumab, a biotechnology drug, is being considered for
patients with advanced HER2-positive breast cancer who have not
received prior treatment or who have suffered a relapse
"We have been researching HER2-positive breast cancer for
more than 30 years, and we hope an expedited review will help us
quickly bring another personalized medicine to people battling
this aggressive disease," Hal Barron, Roche's chief medical
officer, said in a statement.
Herceptin, which like pertuzumab was discovered by
Genentech, was approved in 1998 as one of the first drugs
considered to be an example of personalized medicine. It had
2010 global sales of $6.8 billion.
HER2 is a protein produced by a cancer-linked gene generated
by about a quarter of breast cancer patients. As with Herceptin,
only patients deemed to be HER2-positive are eligible for
treatment with pertuzumab.
Roche shares closed up 1.9 percent in Switzerland.