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Gilead (GILD) Breast Cancer Drug Gets Positive CHMP Opinion

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Gilead Sciences, Inc. (GILD - Free Report) recently announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has adopted a positive opinion on the Marketing Authorization Application (MAA) for sacituzumab govitecan. It is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor.

Sacituzumab govitecan is approved under the trade name Trodelvy in metastatic triple-negative breast cancer (TNBC) in the United States.

The MAA is seeking approval of the candidate as a monotherapy indicated for adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for advanced disease.

A final decision from the European Commission for sacituzumab govitecan is anticipated later in 2021.

The positive opinion was based on results from the ASCENT study, where sacituzumab govitecan showed a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death and improved median progression-free survival (PFS) to 4.8 months from 1.7 months seen with physician’s choice of chemotherapy alone among all randomized patients, which included those with and without brain metastases.
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers.

Approval in additional geographies will boost the growth potential of the drug.

Gilead continues to evaluate sacituzumab govitecan for potential use in other TNBC and metastatic urothelial cancer. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer.

Gilead’s stock has gained 14.4% this year against the industry's decline of 11%.

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The decline in its HCV business has forced Gilead to diversify into the oncology space, which promises potential despite stiff competition.

HIIV therapy, Biktarvy, continues to drive growth despite the ongoing impact of the pandemic. However, the loss of exclusivity of Truvada and Atripla has affected the HIV franchise’s performance. Competition is stiff as well from the likes of GlaxoSmithKline (GSK - Free Report) .

Gilead has collaborated with a subsidiary of Merck (MRK - Free Report) to develop and commercialize long-acting, investigational treatment combinations of Gilead’s lenacapavir and Merck’s islatravir in HIV.

Gilead currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Regeneron Pharmaceuticals (REGN - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings estimates have been revised upward by 3.3% for 2021 and 0.3% for 2022 over the past 30 days. The stock has surged 13.6% year to date.