Over the last 15 years, we have witnessed a notable shift in oncology drug development activity. Since the U.S. approval of Roche/Genentech’s Herceptin (trastuzumab) in 1998, pharmaceutical companies have been choosing to find new commercial opportunities through the development of personalized therapies. The rise of personalized treatments offers the opportunity for high treatment value despite intentionally targeting niche patient populations defined by physiological status or molecular characteristics of tumors. The era of one-size-fits-all chemotherapy treatment is drawing to a close for many oncology indications, and blanket use of chemotherapy across all patient subtypes is being replaced or added to with personalized therapies. However, while considerable clinical and commercial opportunities remain for further development of personalized therapies, the entrance of and excitement surrounding immune checkpoint inhibitors in oncology suggest novel drugs can still capture significant sales while targeting wide patient populations without exploiting biomarkers. Nevertheless, in biomarker-defined niche segments, molecularly targeted therapies present extremely strong competition, and with further investment, such therapies will continue to shape medical practice and provide meaningful market opportunities.

Questions Answered in This Report:

  • Since the U.S. approval of Roche/Genentech’s Herceptin (trastuzumab) in 1998, pharmaceutical companies have been choosing to find new commercial opportunities through the development of personalized therapies. Which personalized therapies have reached the market and which biomarkers do they rely on? Which companion diagnostic companies have already exploited the opportunities presented by personalized therapies?

  • Despite the advantages of developing personalized therapies, there are numerous challenges to overcome. How can developers of personalized medicines overcome these barriers and best exploit the opportunities?

  • The rise of personalized therapies in oncology impacts multiple different stakeholders, from pharmaceutical companies, through to diagnostic companies, patients, and payers. What is the impact and implications of of personalized therapies for these key stakeholders? What future events involving personalized therapies are anticipated?

  • As a greater number of personalized therapies reach the market, some targeting novel biomarkers, the field is rapidly evolving; personalized therapies compete with other biomarker-driven agents within their niche segments but also with non-personalized therapies. What do interviewed thought leaders believe is the future for personalized therapy in oncology? What advice do key opinions leaders give to companies pursing the development of novel biomarker-associated drugs? To what extent can new drugs that are not associated with biomarkers compete in an era of personalized therapies?
Author(s): Andrew Merron, Ph.D.

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