Gilead Sciences, Inc
.
GILD
announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for oncology drug, sacituzumab govitecan-hziy (SG).
The candidate is already approved (accelerated basis) under the brand name, Trodelvy, in the United States to treat adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease.
The MAA is seeking approval of the candidate for the treatment of adult patients with unresectable locally advanced or metastatic TNBC, who have received at least two prior therapies, including at least one prior therapy for locally advanced or metastatic disease.
The application is under accelerated review by the EMA. The agency granted accelerated assessment based on positive results from the phase III ASCENT study.
A tentative approval in Europe will increase the sales potential of the drug, given the market potential.
It is also under review by the FDA for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting.
It is also being evaluated in hormone receptor-positive/HER 2-negative metastatic breast cancer and metastatic non-small cell lung cancer, either as a monotherapy or in combination with other agents.
The acquisition of Immunomedics, Inc. in October 2020 added Trodelvy to Gilead’s oncology portfolio, which comprises cell therapies like Yescarta and Tecartus. The massive decline in sales of its HCV franchise has led the company to focus on the HIV franchise and the oncology portfolio.
While the breast cancer market has potential, given the widespread prevalence, competition is stiff in this space from
Roche
’s
RHHBY
strong portfolio of drugs like Perjeta, Kadcyla and Tecentriq and
AstraZeneca
AZN
and
Merck
’s
MRK
Lynparza (olaparib).
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