Abstract
Abstract For most forms of cancer there is high unmet need. This is especially the case for advanced cancer. Improved understanding of mechanisms of unresponsiveness to currently available treatments and identification of novel drugable targets have boosted anticancer drug development, often leading to so-called breakthrough medicines, i.e. drugs that can dramatically improve cure rate and survival. The monoclonal antibodies (mAb) trastuzumab and rituximab and the tyrosine kinase inhibitor (TKI) imatinib, developed in the recent past, deserved this qualification. These drugs have not only changed the standard of practice, they also served as template for new drug development leading to EMA & FDA approval of >30 novel mAbs and TKIs for cancer indications since the introduction of rituximab in 1998. However, this does not guarantee swift patient access to new medicines nor to equal access for all indicated patients. Also, some drugs with high anticancer potential in well defined cancer populations simply seem to be stuck in development. One of the examples of missed opportunities is the group of the PARP inhibitors (PARPi): first patient included in phase I was in the year 2005 and now almost a decade later there is still no availability worldwide for well characterized populations with BRCAm, including breast and ovarian cancer, of PARPi treatment. Clearly, there is room for improvement, for which there is a range of good opportunities: shorten time to registration, shorten time to reimbursement, improve patient selection, limit to well defined subsets and expand later, setup global biomarker networks, setup global well controlled access programs and lastly take more risk. These opportunities will be discussed and examples will be given. Citation Format: Jan H. M. Schellens. Improving access to innovative anticancer medicines: a clinicians viewpoint [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr SF1-2.
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