Jyoti Madhusoodanan in Nature:
In August 2021, Amol Akhade, an oncologist at Nair Medical Hospital in Mumbai, India, received an e-mail from the Swiss drug manufacturer Roche recommending the use of a drug named atezolizumab to treat a specific kind of breast cancer. Akhade was surprised. That month, Roche had withdrawn the drug for this purpose in the United States (although it is still approved to treat other kinds of cancer).
For the type of breast cancer in question — known as triple-negative because it lacks three key protein markers — atezolizumab was made available in 2019 through the US Food and Drug Administration’s (FDA’s) Accelerated Approval Program. Accelerated approval is a fast-track process designed to place desperately needed drugs in the hands of patients quicker than is possible with conventional drug approval. But a follow-up study found that atezolizumab made little difference to tumour growth, and that people who received it were less likely to survive up to two years after treatment than were those not taking it1. When the FDA received these data in 2021, it indicated that accelerated approval was no longer appropriate, and Roche withdrew the drug for this form of breast cancer. The same thing happened with the European Medicines Agency (EMA), based in Amsterdam, but not everywhere else.
In India, for example, where the drug was still approved for triple-negative breast cancer, Roche continued to promote the treatment until at least September, a fact that Akhade says he found “quite shocking”.
More here.