FDA grants Roche’s pertuzumab priority review
pharmafile | February 10, 2012 | News story | Sales and Marketing | Herceptin, Roche, pertuzumab
The FDA has accepted Roche’s potential breast cancer treatment pertuzumab for appraisal and granted the drug priority review.
The proposed licence is for pertuzumab to be used with Roche’s established HER2+ breast cancer drug Herceptin (trastuzumab) and docetaxel chemotherapy.
It is seeking to treat 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.
A priority review speeds up the process of assessing a drug, and the FDA said its action date for pertuzumab was 8 June. A normal evaluation of a drug takes between 10 – 12 months.
The agency grants priority review to products that are considered to be potentially significant therapeutic advancements over existing therapies.
Herceptin is one of Roche’s biggest selling drugs, and brought in CHF5.3 billion ($5.8 billion) last year, but will start to lose patent protection soon. Pertuzumab is expected to make $1.8 billion in peak annual sales.
Hal Barron, head of global product development, said: “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.”
The pertuzumab application is based on results from the pivotal Phase III CLEOPATRA study.
The study showed pertuzumab with Herceptin and docetaxel increased median progression-free survival by an extra six months, compared to patients that received Herceptin and chemotherapy alone (median PFS was 18.5 against 12.4 months).
People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death, the study showed.
Overall survival data from that trial is not expected to be available until 2013 however, as it is a longer-term study.
Pertuzumab is an antibody being studied in early and advanced stages of HER2-positive breast cancer and advanced HER2-positive gastric cancer.
The drug is a HER2 dimerisation inhibitor, which Roche says is unique as it is designed specifically to prevent the HER2 receptor from pairing (dimerising) with three other HER receptors.
By preventing receptor pairing, pertuzumab is thought to block cell signalling, which may inhibit cancer cell growth or lead to the death of the cancer cell.
The mechanisms of action of pertuzumab and Herceptin are believed to complement each other as both bind to the HER2 receptor, but on different regions.
Roche has also submitted its drug to the EMA for pertuzumab for patients with previously untreated HER2-positive metastatic breast cancer, and expects a decision later this year.
Ben Adams
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