Gilead has sought regulatory approval for the drug in overseas markets, including the U.K., Canada, and Australia.
DreamstimeThe U.S. Food and Drug Administration late Wednesday issued full approval to Gilead Sciences ’ breast cancer drug Trodelvy for certain groups of patients, expanding on the accelerated approval the drug received just over a year ago.
Trodelvy is now fully approved to treat patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two prior systemic therapies, at least one for metastatic disease . The April 2020 approval was slightly narrower, and was conditional on the completion of a Phase 3 trial.
That trial showed 57% reduction in the risk of disease worsening or death in patients on Trodelvy, and a 49% reduction in the risk of death compared to patients who received a single-agent chemotherapy.
Gilead (ticker: GILD), in a statement, called Trodelvy the first treatment for metastatic triple-negative breast cancer shown to improve progression-free survival and overall survival.
“Today’s approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC,” said Gilead’s chief medical officer, Dr. Merdad Parsey, in a statement.
Shares of Gilead were up 0.9% in premarket trading on Thursday. The stock is up 12.6% so far this year, and down 10.8% over the past twelve months.
Trodelvy was developed by the biotech Immunomedics, which Gilead acquired in September for approximately $21 billion.
Gilead said it had made regulatory submissions for approval for Trodelvy in a number of overseas markets, including the U.K., Canada, and Australia.
Gilead trades at 9.3 times earnings expected over the next 12 months, close to its 5-year average of 9.6 times, according to FactSet. Of the 32 analysts covering the stock who are tracked by FactSet, half rate the stock Buy or Overweight, while 14 rate it a Hold, and two rate it a Sell.
Gilead said that the safety profile of Trodelvy in the confirmatory Phase 3 study was consistent with the drug’s accelerated approval label. Five percent of the patients receiving Trodelvy in the study stopped due to adverse reactions.
“Building upon this milestone, we are committed to advancing Trodelvy with worldwide regulatory authorities so that, pending their decision, Trodelvy may become available to many more people around the world who are facing this difficult-to-treat cancer,” Parsey said.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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FDA Grants Full Approval to Gilead Breast Cancer Drug - Barron's
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