AbbVie ABBV announced that the European Commission (“EC”) has granted marketing authorization to Elahere (mirvetuximab soravtansine) for treating platinum-resistant ovarian cancer.

The EC has approved Elahere for treating adult patients with folate receptor-alpha (FRα) positive, platinum-resistant and high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatments.

Following the approval, Elahere became the first and only FRα-directed antibody drug conjugate (ADC) approved specifically for patients with FRα positive, platinum-resistant ovarian cancer in the European Union.

Elahere was granted full approval by the FDA for a similar indication in March 2024. The drug was initially approved for this indication under the accelerated pathway in 2022.

Shares of AbbVie have gained 6.5% so far this year compared with the industry’s rise of 3.4%.

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EU Nod Based on ABBV's MIRASOL Study

The latest approval in Europe was based on data from the phase III MIRASOL study, which evaluated Elahere against the investigator's choice of single-agent chemotherapy in the given patient population.

Data from the study showed that treatment with Elahere reduced the risk of tumor progression or death by 35% compared with investigator's choice of chemotherapy — the primary endpoint of the MIRASOL study.

Also, treatment with Elahere improved overall survival — demonstrating a 33% reduction in the risk of death versus the investigator's choice of chemotherapy.

The approval in Europe was expected as in September the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended approval for Elahere for the given indication.

More Updates on ABBV's Elahere

A first-in-class ADC, Elahere, was added to AbbVie’s portfolio in February this year following the acquisition of ImmunoGen for $10.1 billion.

ADCs are next-generation treatments that target cancer cells by delivering highly potent cancer-killing agents through a targeted antibody.

In June, AbbVie reported positive results from the phase II PICCOLO study, which evaluated Elahere in heavily pre-treated patients with FRα-positive platinum-sensitive ovarian cancer. The study achieved its primary endpoint as patients treated with Elahere achieved an objective response rate of 51.9%.

Elahere generated sales worth $331 million during the first nine months of 2024. The drug is also being studied for earlier lines of therapy in ovarian cancer. Potential label expansion of the drug is likely to boost sales in future quarters.

ABBV's Zacks Rank & Key Picks

AbbVie currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR, ANI Pharmaceuticals, Inc. ANIP and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 53.8%.

IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 2.6%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 30.2%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

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