On Wednesday the Food and Drug Administration granted accelerated approval to Immunomedics (NASDAQ:IMMU) for its antibody drug conjugate treatment for triple-negative breast cancer (TNBC). The treatment, which has the generic name sacituzumab govitecan, will be marketed by the company as Trodelvy. It's the first pharmaceutical to be approved for metastatic TNBC, and will be given to patients who have received two prior treatments for the disease.
"We are proud to bring Trodelvy to patients with metastatic TNBC who are in dire need of new options. Trodelvy has the potential to become a standard of care in the management of TNBC, and we anxiously await the results of ongoing studies in other types of metastatic breast cancer," said Dr. Loretta M. Itri, the chief medical officer of Immunomedics.
Trodelvy will carry a black box warning for severe neutropenia (a low count of a type of white blood cell) and severe diarrhea. The drug is expected to become a blockbuster. It is also being tested for other indications, including bladder and lung cancer. Seattle Genetics once offered a $2 billion deal to acquire the drug, and the initial agreement led to a proxy fight for control of Immunomedics.
Indeed, not one but two CEOs lost their job over the fate of Trodelvy. The founder of the company, Dr. David Goldenberg, and CEO Cynthia Sullivan, his wife, both left the company after the Seattle Genetics deal was scuttled and they lost a proxy fight with the company's top investor, hedge fund venBio. Then Sullivan's successor, Michael Pehl, lost his job last year after the FDA declined to approve Trodelvy because of manufacturing issues.
Immunomedics has put together a 130-person sales force to introduce the drug to physicians. Its stock has doubled over the last month.