The US FDA has approved Roche's Perjeta, a personalised medicine for breast cancer, whilst cautioning that production problems could affect supply of the product.
The agency has approved Perjeta (pertuzumab) as a treatment for previously-untreated HER2-positive metastatic breast cancer in combination with Roche's $6bn-a-year blockbuster anti-HER2 therapy Herceptin (trastuzumab) and docetaxel.
The approval only extends to batches of the product that are unaffected by a cell culture issue that has affected the consistency of the production process for the drug, which is made by Roche's Genentech unit, according to the FDA.
"Given the need for additional treatments for metastatic breast cancer, we made the decision to approve this drug today and not to delay its availability to patients pending resolution of the production issues relating to future supply," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER).
"Genentech is currently developing a plan to mitigate the effect on patients of any potential shortage of Perjeta," she added.
Approval was granted on the back of the CLEOPATRA study, which showed that the combination of Perjeta, Herceptin and docetaxel extended progression-free survival (PFS) by 6.1 months to 18.5 months compared to Herceptin and docetaxel alone.
Roche said the new drug regimen was the first to show an increase in PFS compared to Herceptin plus chemotherapy.
"We expect to meet demand for Perjeta," said Patrick Yang, head of pharma global technical operations at Roche.
"We take this very seriously and are working with the FDA to ensure a consistent manufacturing process that maintains drug supply for the people who need it."
Assuming Roche's manufacturing issues for Perjeta are resolved swiftly, analysts have predicted sales of $600m to $1bn for Perjeta within the next five years, which will help soften the blow when Herceptin starts to lose patent protection in 2015.
Meanwhile, Roche has further developments in its anti-HER2 pipeline. Last week, Roche presented results from a phase III trial of Herceptin follow-up T-DM1 (trastuzumab emtansine) which showed it extends PFS of metastatic breast cancer, setting up possible FDA approval later this year.