Roche has moved a step closer to securing EU approval for personalised breast cancer drug Perjeta, following a positive recommendation by the Committee on Medicinal Products for Human Use (CHMP).
The CHMP said Perjeta (pertuzumab) should be approved for use alongside Roche’s $6bn-a-year breast cancer drug Herceptin (trastuzumab) and docetaxel in patients with HER2-positive metastatic or locally recurrent unresectable breast cancer.
Perjeta was approved for this indication in the US earlier this year and has also been given the go-ahead in Switzerland and Mexico.
Roche supported its application with data from the CLEOPATRA study, which showed that the combination of Perjeta, Herceptin and docetaxel reduced the risk of progression-free survival (PFS) by 34 per cent compared to patients receiving Herceptin and chemotherapy alone.
Roche noted that the new drug regimen is the first to show an increase in PFS compared to Herceptin plus chemotherapy.
Analysts have predicted that sales of Perjeta could reach $600m to $1bn within the next five years, which will help alleviate the impact of generic competition to Herceptin, which starts to lose patent protection in 2014.
There is debate about access to the new drug, however – particularly in the EU where many countries are in the midst of austerity drives – given that the cost of Herceptin plus Perjeta will be in the region of $188,000 a year, according to a Reuters report.
Meanwhile, Roche has additional drugs coming through its breast cancer pipeline, and in October presented results from a phase III trial of Herceptin follow-up T-DM1 (trastuzumab emtansine) which showed it extends PFS in metastatic breast cancer.
T-DM1 was filed in the US earlier this year and could be approved for marketing within the next few weeks.
Roche is also developing additional products intended to protect its Herceptin franchise, including a subcutaneous formulation of trastuzumab – partnered with Halozyme Therapeutics – that is also in the latter stages of development.