Cancer Drugs are least likely to receive FDA Approval,

There was a new study of potential cancer drugs that gives insight into which experimental therapies are best predicted to one day enter the market.

Due to the sheer size of the study, it was run by multiple parties; Biotechnology Innovation Organization (BIO), the largest biotech trade association, and BioMedTracker and Amplion, two business intelligence firms.

The study found that drugs that target blood disorders have the greatest chance of receiving FDA approval while cancer drugs have the smallest changes.

Dave Thomas, the main author from Biotechnology Innovation Organization, explained that this is largest study of its kind. Over 10 years of data was analyzed following human clinical trials.

Human clinical trials occur in three phases, allowing the progression of the experimental therapy to be measured.  On average, there is less than a 10% chance of a potential drug to pass from phase I to phase II.  Phase I focuses only on the safety of the drug, while phase II and III focus on efficacy of the drug.

The study compared medications to target blood disorders, infectious disease, eye diseases, psychiatric and cardiovascular issues, cancers and others.

Drugs targeting blood disorders, hematology, had the greatest approval rating at just above 26%. Infectious diseases and ophthalmology (eye diseases) had similar chances at about 19% and 17% respectively. Cancer drugs ranked in the bottom along with psychiatric and cardiovascular medications with about a 5%, 6.2% and 6.6% approval rating likelihood, respectively.

The study also demonstrated that drugs with highly-personalized clinical trials, where the patients being treated were relatively homogenous. It is easier to form a therapy when the target is more similar.

The FDA also gives priority to medications for rare disorders.

Here's the source article.



Gerry Oginski
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