Cancer Drugs Are The Least Likely to Receive FDA Approval

A massive new study of drug candidates sheds light on which experimental therapies are most likely to eventually reach the market.

The report was compiled by biotech’s largest trade association, the Biotechnology Innovation Organization (BIO), with the help of business intelligence firms BioMedTracker and Amplion, and it found that drugs for blood disorders have the highest probability of ultimately winning FDA approval. Meanwhile, cancer drugs have the lowest chance of receiving the go-ahead.

BIO’s Dave Thomas, the report’s author, noted that the study is the largest-ever of its kind in an interview with Fortune. The study examined a decade’s worth of data (2006-2015) encompassing just under 10,000 “phase transitions,” a term for an experimental therapy’s progression through three phases of human clinical trials, regulatory filing, and ultimate approval.

On average, a drug candidate had a 9.6% chance of going from phase I trials to winning the FDA’s blessing, according to the study. Transitions from phase I to phase II were the most successful—not too surprising given that phase I trials only assess safety and not effectiveness. Progressing from small phase II efficacy studies to far larger phase III ones proved the most challenging.

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