Effort To Launch Breast Cancer Treatment Shows Complexities Of Drug Development

[News]

The case of Genentech's breast cancer treatment T-DM1 demonstrates the challenges of balancing regulatory oversight with patients' desire to access experimental medications and drugmakers' business interests, the Boston Globe reports. Ensuring a drug is safe requires years of clinical trials and extensive evaluations by regulators and companies...

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[schoonder]

IMO this article doesn't do a good job of addressing actual issue at hand. It talks about FDA's role of ensuring that drug is safe, but in T-DM1's case FDA for some absurd and surely with respect to targeted medicine outdated reason refused to even consider looking at the data. That decision send this program in a two-plus year tailspin.