An FDA approval four decades in the making

It only took 37 years, a brush with death, and a messy fight with a hedge fund, but Immunomedics is finally on the verge of its first FDA approval.

As STAT’s Adam Feuerstein reports, the company is widely expected to get a green light for an injectable treatment meant to help women with breast cancer that hasn’t responded to standard therapy. Immunomedics’ drug, called sacituzumab govitecan, charted a 34 percent response rate in an open-label trial, results that compare favorably with the effects of chemotherapy.

If Immunomedics can win over the FDA, sacituzumab govitecan will end a decades-long scientific drought, one that sparked an investor revolt and forced a change in management.

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