Modeling for Quicker Approvals of Cancer Drugs

Genentech. Retrieved from http://rxhq.files.wordpress.com/2012/06/perjeta.jpg

In the article, “F.D.A Panel Backs Pre-surgery Drug for Breast Cancer”, Andrew Pollack talks about the first approval of a cancer drug by a federal advisory committee to the Food and Drug Administration.  The drug, Perjeta, is a Genentech drug that is already approved by the F.D.A for late-staged breast cancer, but could also be used during the earliest stages of breast cancer. In the early stages, the drug may help make operating on previously inoperable tumors possible, or to make the tumors small enough so that a breast-conserving surgery is possible.  The approval of Perjeta would allow more women to gain access to the drug years earlier than they might otherwise because as the first neoadjuvant drug approved for any cancer, it would presumably be easier to obtain insurance reimbursements.  The approval of the Perjeta may also set a precedence to make approvals for cancer drugs faster and more efficient.  This is because if the drug can be tested in the early stages of cancer, then the drug’s effectiveness against the cancer can be more clearly observed.  In all, the approval of Perjeta would allow for more cancer drugs to be approved faster, but the drug’s efficiency against breast cancer is still to be determined with extensive trials.

 

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