Personalised cancer drug wins first European approval
Perjeta has been tipped as a potential blockbuster (image: Roche)
Roche has been granted the first European approval for its personalised cancer medicine Perjeta, with Swiss regulatory authorities clearing it for the treatment of HER2-positive breast cancer.
Perjeta (pertuzumab) is indicated in Switzerland for use alongside Herceptin (trastuzumab) and docetaxel in patients with advanced or locally recurring breast cancer that has not previously been treated with chemotherapy.
A marketing application for the drug in the EU is still under review at the European Medicines Agency (EMA), although it was approved earlier this year by the US FDA and made 4m Swiss francs ($4.1m) in its first few weeks on the market, according to Roche's first half results statement.
Perjeta has been tipped as a potential blockbuster with peak sales of $600m to $1bn in the next five years, but celebrations about the new approval will likely be somewhat muted by ongoing production issues for the drug at Roche subsidiary Genentech.
Back in June, the FDA said it approved the drug - despite a problem with the cell culture used to make the active substance in Perjeta that was generating low yields and likely to cause supply constraints - because there was a "need for additional treatments for metastatic breast cancer".
The drug’s new approval by Swiss Medic 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. The new drug regimen is the first to show an increase in PFS compared to Herceptin plus chemotherapy.
Roche insists it will be able to meet near-term demand for Perjeta and is working to solve the manufacturing issues, and chief executive Severin Schwann provided an upbeat assessment of its prospects earlier this week, saying that "there is no doubt that this medicine will shift the standard of care in the treatment of HER2-positive breast cancer".
Schwan said on Roche's first-half conference call that the manufacturing issues have been largely resolved, as the problem did not extend back to the master cell line developed to produce Perjeta and the company has been able to generate a new cell line with a better yield.
Meanwhile, development of Perjeta continues apace, with overall survival data from the CLEOPATRA study due later this year.
Roche is also looking at the drug in combination with its Herceptin follow-up candidate trastuzumab emtansine (T-DM1) in a trial called MARIANNE, as well as running the APHINITY study of Herceptin and Perjeta in the adjuvant breast cancer therapy setting, and these two should have results before year-end.