Chemotherapy drug Taxotere is under fire not only for allegedly causing permanent hair loss, but also because drugmaker Sanofi SA allegedly falsely marketed the drug’s “superior efficacy” compared to similar competing drugs. According to Law360, one suit against the pharmaceutical company alleges that the company based its marketing on self-sponsored clinical trials while other studies were finding that competing drugs were more effective in certain patients.
“Contrary to defendants’ claims of superior efficacy, post-market surveillance has shown that the more potent and more toxic Taxotere does not, in fact, offer increased efficacy or benefits over other taxanes, as defendants have claimed and advertised,” according to the complaint, reports Law360. “Defendants concealed the existence of studies from the FDA, physicians and patients that refuted defendants’ claims.”
In 2009, the Food and Drug Administration (FDA) issued a warning letter to Sanofi about its practices.
In fact, another study has found Taxotere to be less effective in certain patients. According to Lung Cancer News Today, the FDA has just approved Genentech’s Tecentriq (atezolizumab) to treat certain patients with previously treated metastatic non-small cell lung cancer (NSCLC). This drug is approved for those whose disease progressed after platinum-based chemotherapy or whose disease continued after another FDA-approved targeted therapy when their tumors had certain gene abnormalities.
The Phase 3 OAK study that tested its safety and effectiveness for FDA approval compared Tecentriq with Taxotere in 1,225 patients. “Preliminary data from the first 850 patients enrolled revealed that Tecentriq produced a 4.2-month improvement in patients’ overall survival compared to Taxotere (13.8 months vs. 9.6 months). Objective response rates were similar between both groups, but median duration of response to Tecentriq was more than double that of Taxotere,” reported Lung Cancer News Today.
According to Law360, the complaint alleges that false marketing touting “superior efficacy” was all part of a successful scheme to drive up sales that started in 1996 when the drug was approved by the FDA and included illegally promoting the drug for off-label use, misrepresenting the drug’s safety and effectiveness for off-label use, and giving kickbacks to health care providers who prescribed it off-label, as well as concealing the fact that the drug caused permanent hair loss.