US biotechnology giant Genentech, which is majority-owned by Swiss pharmaceutical major Roche, is seeking a green light in the USA to market the group's breast cancer drug Herceptin (trastuzumab) for the treatment of early-stage forms of the disease.
Herceptin received its first approval, to treat advanced breast cancer, in the USA in 1998, and raked in sales of $747.2 million last year for the firm. An indication for early breast cancer could substantially boost the product’s sales and, if the FDA grants the application a speedy review as requested, this will mean a decision within six months.
Genentech’s submission for early breast cancer is based on two Phase III trials, involving 3,000 patients whose breast cancer had not spread beyond the breast and lymph nodes, which show that adding Herceptin to standard regimens can cut the risk of breast-cancer recurrence in patients by a whopping 52%.
And it is the drug’s potential for treating early forms of the disease that has gained it increasing media attention on the other side of the Atlantic, where women have been fighting for free access to Herceptin for this indication under the UK’s National Health Service.
Just yesterday, a 54-year-old early breast cancer sufferer lost a battle in London’s High Court over her Primary Care Trust’s refusal to shell out for the drug, which is also not yet approved for this indication in Europe. Roche has indicated that it will be filing Herceptin for this use early this year but, until it is approved, the National Institute for Health and Clinical Excellence - the country's cost-effectiveness body - cannot endorse its use on the NHS.
This latest decision marks a turnaround as, in similar cases over the last few months, health authorities have reneged on their initial decisions not to pay for the drug, sparking concerns that patient and political pressure is interfering with the regulatory safety nets put in place to protect the public from problems with new drugs or indications.
After Elaine Barber won her fight for access to the product late last year, the country's NHS Confederation, which represents more than 90% of NHS organizations, commented: "PCTs now find themselves placed under huge public pressure if they do not prescribe Herceptin for use in early-stage breast cancer on the grounds of safety and cost-effectiveness. We are concerned that PCTs are being put in an almost impossible position by growing pressure to bypass systems established to protect patients."