Deloitte released a new report, "Innovative Strategies for Oncology Drug Development," highlighting specific drug development approaches that have enabled biotech companies to produce a substantial number of first-in-class compounds and more than $1 billion in oncology drugs while transforming the medical outlook for many cancer patients.
"Scientific innovation has brought measurable rewards such as reduced development times, higher success rates for cancer drugs, and increased investment and activity across the biopharmaceutical industry," said Lisa Natanson, senior analyst, Deloitte Recap LLC. "We see clear patterns of successful drug development from this study of a defined set of biotechnology companies that have produced innovative cancer drugs in the last decade."
By analyzing the drug development patterns of the Deloitte Recap BioPortfolio Index (RBI) companies, a select group of more than 150 biotechnology companies that have been tracked and benchmarked for more than a decade, Deloitte identified the following key findings:
- FDA-approved oncology compounds all heavily utilized at least one (and some as many as four) special U.S. regulatory mechanisms, such as Fast Track designation, Orphan Drug status, or Accelerated Approval, to speed clinical development and reduce FDA transit times.
- Orphan indications served as an initial market entry point to billion dollar markets followed by label expansion efforts to broaden the patient populations.
- Innovative agents, such as those targeting receptor tyrosine kinases, achieved up to 31 percent approval success rates.
"Overall, the findings of this report demonstrate that the biotech industry is having a measurable impact on developing new therapies in the 'war on cancer,'" concluded Matthew Hudes, national managing principal of the biotechnology practice for Deloitte Consulting LLP.
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