US FDA Oncologic Drugs Advisory Committee panelists who were granted financial conflict-of-interest waivers to participate in the agency’s multi-day review of accelerated approvals for three immunotherapies voted in favor of keeping the indications at issue on market more than three-quarters of the time. Non-conflicted experts voted in favor only two-thirds of the time. One of the six panel outcomes would have been different without the conflicted members’ votes.

The UK's National Institute for Health and Care Excellence (NICE) has included Myriad Genetics' EndoPredict in its recommendations for guiding adjuvant chemotherapy decisions for certain early breast cancer patients. The recommendation comes just a few weeks after new data showing the long-term prognostic value of the EndoPredict test was presented at the San Antonio Breast Cancer Symposium. The company is also making progress on its Vectra rheumatoid arthritis prognostic system with the publication of a large commercial cohort and several clinical studies on development of the adjusted Vectra score.

Immuno-oncology has significant diagnostic needs including identifying patients most likely to respond to therapies. Current diagnostic approaches often fall short, due in large part to the complexity of the biology driving therapy responsiveness. As such, the biopharma industry is exploring many emerging approaches covering tumor, immune and even microbiome-related pathways and biomarkers.

The rapidly accelerating complexity of oncology drug development demands a new way of doing business. To succeed in this new landscape, biopharma companies must transform their portfolios and partnerships, and shift toward more dynamic business and operating models and decision-making processes.