Research that appeared last week in The Lancet suggests that a new-generation cancer drug could be a superior alternative to Taxotere, which has recently been linked permanent alopecia. Among other things, the study found that non-small cell lung cancer patients treated with Tecentriq (atezolizumab) suffered fewer side effects and lived longer compared to those who received the older chemotherapy agent.
Publication of the study comes as hundreds of plaintiffs pursue Taxotere lawsuits after allegedly suffering permanent hair loss due to its use. These plaintiffs claim that Sanofi-Aventis failed to warn patients and doctors that alopecia caused by Taxotere is more likely to be permanent compared to other, equally effective chemo drugs.
Tecentriq was approved in October 2016, and is indicated to treat non-small cell lung cancer. The Lancet study, which was funded by the drug’s manufacturer, found that Tecentriq patients had a median overall survival of 13.8 months, compared to 9.6 month for individuals treated with Taxotere. Around 15% of those in the Tecentriq group had treatment-related grade 3 or 4 adverse events, versus 43% in the Taxotere group. The study did not, however, indicate what the specific side effects were.
Taxotere was approved by the U.S. Food & Drug Administration (FA) in 1996 to treat breast cancer. Its approved indications now include head and neck cancer, gastric cancer, prostate cancer and non-small cell lung cancer. Mention of permanent alopecia as a possible side effect was only added to Taxotere’s U.S. labeling in December 2015.
More than 700 Taxotere hair loss claims have been centralized in a federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. Among other things, the complaints cite several studies that suggest patients treated with Taxotere are more likely to experience permanent alopecia compared to those who receive other chemo drugs. The filings also highlight a warning letter that Sanofi-Aventis received from the FDA in 2009, which cited the company for making allegedly “false or misleading statements concerning unsubstantiated claims of Taxotere’s superior efficacy.” Finally, plaintiffs point out that Sanofi has provided information regarding the potential for permanent alopecia to individual patients and regulatory agencies overseas. Yet the U.S. label only included a generic, vague, and insufficient warning that “hair generally grows back”