Dive Insight:

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.