UPDATE 2-Roche breast cancer drug gets FDA priority review

Tue Feb 7, 2012 1:40pm EST

* 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 (Reuters) - 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 following surgery.

"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.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.