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Prostate Cancer Drug Development in Europe: Collaboration for Solution

Submitted by on 06 Oct 2011 – 10:23

Prostate Cancer Drug Development in Europe: Collaboration for Solution Edwina Baskin-Bey, M.D., Sue Jones, PhD., Kevin Hartley, BSc, Chris Thomson, PhD., Frank Perabo, M.D., PhD., Stefan Holmstrom, MSc, SteveVan Os, M.D. Astellas Pharma Europe Ltd. & Astellas Pharma Europe B.V

Prostate cancer is being diagnosed more than in the past, and, as a consequence, patients are often being treated at an earlier disease stage. In contrast to patients with more advanced disease, such as those with castration-resistant prostate cancer (CRPC), these earlier-stage prostate cancer patients are generally not at risk of imminent death. However, they are still in need of medicinal treatments that stave off advanced disease.

When patients are treated earlier in the disease continuum, they are necessarily exposed to the effects of treatments for longer. In common with other anticancer therapies, treatments for prostate cancer can have significant side effects that affect health and quality of life. Currently in earlier-stage prostate cancer, hormonal therapy (specifically GnRH analogues) is used in the majority of patients when drug therapy is indicated. These agents result in both short and long-term comorbid conditions that decrease patient quality of life, such as sexual dysfunction, sarcopenic obesity, cardiovascular disorders and insulin resistance. There is therefore an unmet need for new treatments to offer efficacy along with a better side effect profile.

Despite the need for new treatments for patients with earlier-stage prostate cancer, there is little activity in drug development in this setting. This is in part due to the higher assumed interest of regulators and payers in therapies that have demonstrated efficacy in end-stage disease (CRPC), and partly due to the traditional reliance of regulatory authorities on overall survival as a required clinical trial endpoint. For pharmaceutical companies, it is difficult, time-consuming and expensive to demonstrate overall survival benefits in earlier-stage prostate cancer because of the timescales required, the number of patients needed to sufficiently power clinical studies, and the high likelihood of these patients dying of other causes.

The impact of the current situation is that pharmaceutical companies may limit investment in drug development for earlier-stage prostate cancer. To improve the system and better incentivise companies to investigate medicines in earlier prostate cancer, an open forum for discussion would be welcomed. This collaborative effort could include groups and bodies concerned with the development, approval, delivery and receipt of prostate cancer therapies. It could be used to challenge the orthodoxy and accepted wisdom of current paradigms of drug development in prostate cancer, seek to alter limitations that prevent effective therapies reaching patients with earlier-stage disease in a timely manner, and/or offer an arena for Pharma companies to realise how they can combine forces to improve development strategies of novel compounds. [1]

Recently, the FDA’s Oncologic Drugs Advisory Committee broached the topic of trials and endpoints for drugs to treat an earlier segment of the prostate cancer population[2]. Maybe, the first order of business for the EU is to consider the current regulatory framework, e.g. consider what endpoints could be considered appropriate for earlier-disease prostate cancer clinical trials, improve the accelerated assessment procedure for drugs fulfilling a recognised unmet medical need, and introduce mechanisms such as a rolling submission of sections of the MAA. At present, there is an accelerated assessment procedure in the EU. However, it is not as fast as the US FDA priority review system, it is rarely used, and it does not significantly reduce the time taken to get a drug to market compared with the standard process[3].

In conclusion, prostate cancer is being diagnosed earlier, but there are not options available that are both efficacious and provide good long-term quality of life. The current EU regulatory, ethics and reimbursement frameworks for prostate cancer therapies are not conducive to the rapid development of drugs to treat earlier-stage prostate cancer. Therefore, pharmaceutical drug development is currently centred around patients with advanced prostate cancer, namely CRPC. To help solve this problem, it is suggested that a collaborative forum be created for discussing common goals in the treatment of patients with all stages of prostate cancer. This round-table must involve all relevant stakeholders including the pharmaceutical industry, patient groups, physicians, payers, and representatives of the European Medicines Agency (EMA) and the EU Health Commission.

[1] J Bylander , The Gray Sheet 2011 Sept 5. Team Work: Pfizer, Abbott Gain Swift Approvals for Lung Cancer Drug/Test Combo

[2] S Haley, The Pink Sheet Daily 2011 Jul 27. Trial Designs for Non-Metastatic Prostate Cancer on Oncologics Advisory Committee Agenda

[3] A Ault, Elsevier Global Medical News. 2011 June 16, FDA Approves Cancer Drugs Faster Than European Agency