Analysis: Most Cancer Medications Approved With No Proof That They Extend Life.
In a 3,100-word article, the Milwaukee Journal Sentinel (10/26, Fauber) reports that “a Milwaukee Journal Sentinel/MedPage Today analysis of 54 new cancer drugs found that over the last decade the FDA allowed 74% of them on the market without proof that they extended life.” Additionally, there was often no “proof of improved quality of life.” The FDA “instead...approved the drugs based on surrogate measures, such as a tumor shrinking, rather than the gold standard and most reliable measure of cancer research, patients actually surviving longer.” In an email, FDA spokeswoman Stephanie Yao said, “While it is acknowledged that shrinking a tumor or preventing it from progressing may not be a direct measure of improvement in survival, symptoms or function, as the magnitude of that shrinkage or delay in growth increases, our confidence that the result is likely to predict clinical benefit increases.”
In a 1,400-word article, the Milwaukee Journal Sentinel (10/26, Fauber, Chu) reports, “Critics say using surrogate measures to determine if a drug should be approved can backfire. Surrogates can mask complications that work against survival or quality of life, said Richard Deyo, a professor of evidence-based medicine at Oregon Health and Science University.”
The Milwaukee Journal Sentinel (10/26, Fauber, Chu) reports, “While the FDA says it prefers to see high response rates in the drugs it approves based on surrogate measures,” certain “low-response rate” medications “also get on the market.” This is due in part, “the agency says,” to “a lack of alternatives for people with life-threatening cancers.” The Milwaukee Journal Sentinel (10/26) also profiles a patient with colon cancer who is has been taking Stivarga (regorafenib).
Skin Cancer Medicine For Patients With Inoperable Melanoma Gets Approval.
The Tampa Bay (FL) Times (10/27) reports about the recent FDA approval for Merck & Co.’s groundbreaking skin cancer medicine Keytruda (pembrolizumab), belonging to a new class of immunotherapies “that work by blocking a pathway in the immune system known as PD-1.” The medicine was approved for patients with inoperable melanoma. The paper cites the example of 65-year-old Carl Paulk, who is in roofing business, to highlight how effective the medicine has been for some patients. “Before long, his tumors began to shrink; the one in his chest disappeared completely,” the piece notes. According to the paper, “the drug performed so well early in clinical trials that approval was granted before testing is officially completed.” |
