We present an overview of the cancer treatment drugs that have been given approval by the FDA –depending on the response rate’s surrogate point.
The Food & Drug Administration (FDA) of the United States is known to give approval to the cancer treatment drugs from time to time. For giving approval to the drugs, the FDA is known to make use of the Response Rate (RR) parameter as a major determinant to analyze the overall effectiveness of the drug. Response Rate (RR) is referred to as the percentage of cancer patients whose cancer is known to shrink beyond the given arbitrary threshold.
Findings of the FDA Study
As per the study on the success of FDA’s approval on the basis of RR, it was observed that 85 of the drug inclinations with respect to cancer treatment were given approval on the basis of the response rate (RR). The median of RR in such cases was found to be around 41 percent. Out of the 85 cases of approval, around 14 cases (16 percent) had less than 20 percent RR, 28 cases (33 percent) had less than 30 percent RR, and 40 cases (47 percent) had less than 40 percent RR.
Abstract of the Study
The results of the study revealed that most of the cancer treatment drugs are given approval by the FDA on the basis of the modest or low RRs –usually in the case of single-arm studies.
It is assumed that around one-third of cancer treatment drugs are given approval by the FDA on the basis of the response rate (RR). The main objective of the study has been for characterizing the RR surrogate or end points that are used by the FDA (Food & Drug Administration) in the United States for the approval of the right cancer drug. The study aims at exposing information with respect to cancer type, the specific line of therapy including first-line, second-line, or advanced line of cancer treatment, pathway type for FDA approval, sample size, trial design, and the level of innovation that was extracted.