- Gilead has secured full Food and Drug Administration approval for its breast cancer treatment Trodelvy, less than a year after the agency cleared use of the drug under an accelerated approval program.
- The approval is for patients with triple negative breast cancer, an aggressive form of the disease that tests negative for various hormone receptors, who have already tried at least two other therapies. It covers patients whose cancer has advanced locally or spread to other parts of the body and can't be addressed with surgery, Gilead said Wednesday.
- The full clearance is supported by data from a study that showed the drug could delay disease progression and extend survival. The FDA based its earlier conditional approval on research showing that the medication could shrink tumors in a third of patients.
Full FDA approval may give oncologists more confidence in prescribing Trodelvy, which Gilead acquired as part of its $21 billion deal to buy Immunomedics last year. The drug brought in $49 million for Gilead in 2020, after the Immunomedics deal closed in October.
Gilead is counting on Trodelvy to boost its struggling cancer business and lessen its reliance on the company's traditional powerhouse of virus medications. The California biotech is facing declining sales for its HIV drugs Truvada and Atripla amid generic competition.
The company expects Trodelvy to be one of its "key growth drivers" this year, along with the HIV drug Biktarvy and hepatitis therapy Vemlidy, according to its annual report.
In the phase 3 ASCENT trial supporting full FDA approval, researchers found patients given Trodelvy had a median of 4.8 months of progression-free survival, compared with 1.7 months for patients on chemotherapy. The overall survival rate for Trodelvy patients was a median of 11.8 months, compared with 6.9 months for the chemotherapy group.
Trodelvy has the potential to treat multiple tumors, Gilead says. It's studying the medicine's effects in another form of breast cancer, urothelial cancer, lung cancer and other solid tumors. The company said the most frequent serious side effects in the ASCENT study were neutropenia, diarrhea, leukopenia and anemia.