Roche’s new breast cancer drug Pertuzumab up for FDA review

By Dr. Ananya Mandal, MDFeb 7 2012

U.S. health regulators, the Food and Drugs Administration (FDA) has 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. Pertuzumab approval decision is due by June 8^th this year. It could be used with Herceptin in HER2-positive patients. This was announced by Roche Holding AG's Genentech unit 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.

The pivotal Phase III CLEOPATRA study showed that 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. People receiving the treatment also showed a 38 percent drop in the risk of their disease worsening or death, according to Genentech.

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. 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 has also submitted a Marketing Authorization Application to the European Medicines Agency for pertuzumab for people with previously untreated HER2-positive metastatic breast cancer.