Roche and Genentech's pertuzumab for metastatic breast cancer has been accepted for fast-track review by the US Food and Drug Administration (FDA), with an action date set for June 8.
Pertuzumab is one of a new crop of medicines Roche expects will restore growth to its pharmaceutical sales in 2012 and beyond after a challenging period in 2011.
The drug has been filed for use in combination with Roche's Herceptin (trastuzumab) and docetaxel for patients with HER2-positive metastatic or locally recurrent, unresectable breast cancer, who have not received previous treatment or whose disease has relapsed after adjuvant therapy.
The application is based on results from the pivotal phase III CLEOPATRA study, which demonstrated a 6.1 month improvement in median progression-free survival (PFS) for people who received the pertuzumab-based regimen compared to those on Herceptin and docetaxel alone.
Those who received the combination also experienced a 38 per cent reduction in the risk of their disease worsening or death, according to Roche.
Hal Barron, Roche's chief medical officer, said in a statement that new medicines are still needed for HER2-positive breast cancer.
"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 personalised medicine to people battling this aggressive disease," he added.
The market for breast cancer treatments is expected to reach around $10.8bn in seven major pharmaceutical markets by 2020, according to Decision Resources, despite a near-term dip as some of the top-selling products of the last few years lose patent protection.
Herceptin itself is due to lose patent protection within the next 10 years, but the addition of pertuzumab and a modified form of Herceptin (trastuzumab-DM1) to Roche's HER2-targetting franchise will actually boost sales by a $1bn or more, according to the market research firm.