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Seagen (SGEN) Submits BLA to FDA for Cervical Cancer Drug

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Seagen Inc. SGEN along with Danish partner Genmab A/S GMAB announced that they have submitted a biologics license application (“BLA”) to the FDA seeking accelerated approval for the investigational antibody drug conjugate, tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed on or after chemotherapy.

The BLA was based on data from the pivotal phase II innovaTV 204 study which evaluated tisotumab vedotinas a monotherapy for the given indication. Data from the same showed that treatment with tisotumab vedotin led to clinically meaningful and durable responses in this difficult to treat cervical cancer patient population. The candidate demonstrated a manageable and tolerable safety profile.

Per the company, in the United States, more than 13,500 women were expected to be diagnosed with invasive cervical cancer in 2020 which could have resulted in approximately 4,200 deaths from the disease. Hence, if approved, tisotumab vedotin as monotherapy might become an important treatment option for women with recurrent or metastatic cervical cancer, who have experienced disease progression on or after chemotherapy.

The innovaTV 204 study was conducted by Seagen in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups and the Gynecologic Oncology Group Foundation.

Shares of Seagen have declined 3.3% so far this year against the industry’s increase of 12.8%.

price chart for SGEN
price chart for SGEN


In January 2021, Genmab initiated the phase III innovaTV 301 study which is evaluating tisotumab vedotin as compared to chemotherapy for treating recurrent/metastatic cervical cancer in patients who have received one or two prior lines of systemic therapy.

The global randomized study is designed to evaluate the efficacy of tisotumab vedotin as compared with physicians’ choice of single-agent chemotherapy for the given indication.

We remind investors that that Seagen is developing tisotumab vedotin in collaboration with Genmab. The companies share all costs and profits equally for the product.

Apart from cervical cancer, tisotumab vedotin is being investigated as monotherapy in a range of solid tumors including ovarian cancer and in combination with commonly used therapies for metastatic cervical cancer.

Zacks Rank & Stocks to Consider

Seagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. ACOR and Epizyme, Inc. EPZM, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Acorda’s loss per share estimates have narrowed 23.6% for 2021 over the past 60 days. The stock has skyrocketed 78.8% year to date.

Epizyme’s loss per share estimates have narrowed 1.8% for 2021 over the past 60 days. The stock has inched up 2.6% year to date.

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