(Reuters) - 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’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 products that are considered to be potentially significant therapeutic advancements over existing therapies.
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.
Reporting By Bill Berkrot; editing by John Wallace