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Posted On: 04/22/2020 7:07:45 PM
Post# of 154045
Bw, interesting indeed, also look at the results of the 100 women below in a trial.
Immunomedics secured U.S. approval on Wednesday for a new drug to treat women with a particularly aggressive type of metastatic breast cancer.
The Food and Drug Administration disclosed the approval of the new drug, called Trodelvy, on its website. The drug’s review had been held up for more than a year due to problems at Immunomedics’ New Jersey manufacturing facility, now resolved.
“I could not be more proud of the team here, persevering to do what we knew was right to get this drug to patients,” said Behzad Aghazadeh, Immunomedics’ chairman, in a phone call with STAT.
The approval was based on a clinical trial involving more than 100 women with triple-negative breast cancer that was no longer responsive to at least two prior therapies. Thirty-four percent of the women had a partial or complete tumor response to Trodelvy. The median duration of treatment response was nine months.
Immunomedics secured U.S. approval on Wednesday for a new drug to treat women with a particularly aggressive type of metastatic breast cancer.
The Food and Drug Administration disclosed the approval of the new drug, called Trodelvy, on its website. The drug’s review had been held up for more than a year due to problems at Immunomedics’ New Jersey manufacturing facility, now resolved.
“I could not be more proud of the team here, persevering to do what we knew was right to get this drug to patients,” said Behzad Aghazadeh, Immunomedics’ chairman, in a phone call with STAT.
The approval was based on a clinical trial involving more than 100 women with triple-negative breast cancer that was no longer responsive to at least two prior therapies. Thirty-four percent of the women had a partial or complete tumor response to Trodelvy. The median duration of treatment response was nine months.
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