EU Clears AZN's Etcamah Combo for First-Line ER-Positive Breast Cancer

Following the latest nod, Etcamah is now the first and only next-generation oral SERD and complete ER antagonist approved in the first-line setting and the only option in combination with all widely approved CDK4/6 inhibitors.

Year to date, shares of AstraZeneca have declined 7.5% against the industry’s rise of 2.1%.

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EU Nod Based on AZN’s SERENA-6 Study

The approval for the Etcamah combo in the EU was based on data from the phase III SERENA-6 study.

Data from the same showed that treatment with Etcamah in combination with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumor mutation.

The approval in the EU was expected, as in May 2026, the Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion recommending the EU approval of Etcamah in combination with a CDK4/6 inhibitor for the first-line treatment of a certain type of breast cancer.

Etcamah is the 11th new medicine out of the 20 that AstraZeneca expects to launch by 2030, with many of these new medicines already launched/approved.

AZN’s Recent Hurdle With Camizestrant in the United States

In May 2026, AstraZeneca faced a setback when the FDA extended the PDUFA date for reviewing the new drug application (NDA) seeking approval of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the first-line treatment of HR-positive, HER2-negative advanced breast cancer in patients whose tumors have an emergent ESR1 mutation.

The extension follows the FDA’s request for additional data to support the application. This likely delayed the potential approval of the camizestrant combo in the United States.

The extension of the review timeline for camizestrant came after the FDA’s Oncologic Drugs Advisory Committee voted 3-6 against recommending approval of the candidate in combination with CDK4/6 inhibitors for the given breast cancer indication in April 2026.

Last July, the FDA accepted the NDA for camizestrant in combination with a CDK4/6 inhibitor, which was based on positive data from the pivotal phase III SERENA-6 study.

AZN’s Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Kiniksa Pharmaceuticals KNSA and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.30, while estimates for 2027 have increased from $3.64 to $3.87 during the same time. HRMY shares have lost 4.4% year to date.

Harmony Biosciences’ earnings missed estimates in each of the trailing four quarters, with the average negative surprise being 25.16%.

Over the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2026 earnings per share have risen from $1.24 to $1.25, while estimates for 2027 have increased from $1.70 to $1.76 during the same time. KNSA shares have soared 52.8% year to date.

Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 1.53%.

Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $4.92 during the same time. LQDA shares have surged 158.3% year to date.

Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.

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This article originally published on Zacks Investment Research (zacks.com).

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