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Seagen's (SGEN) Tisotumab Vedotin BLA Gets FDA Priority Review

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Seagen Inc. (SGEN - Free Report) , along with its Danish partner Genmab A/S (GMAB - Free Report) , has announced that the FDA has accepted the biologics license application (“BLA”) for investigational antibody drug conjugate, tisotumab vedotin, for the treatment of recurrent or metastatic cervical cancer in patients whose disease progressed on or after chemotherapy.

With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Oct 10, 2021.

In February this year, Seagen and Genmab submitted the BLA to the FDA for the accelerated approval of tisotumab vedotin.

The BLA was based on data from the pivotal phase II innovaTV 204 study, which evaluated tisotumab vedotin as 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.

Per the company, cervical cancer remains one of the leading causes of cancer death in women with more than 311,000 women dying annually from the disease throughout the world. 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.

Shares of Seagen have declined 18.5% so far this year compared with the industry’s decrease of 6.7%.

price chart for SGEN

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

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.

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.

Seagen’s portfolio currently comprises three marketed drugs, namely - Adcetris, Padcev and Tukysa, which are approved for different cancer indications. The company generated net revenues of $2.2 billion in 2020, reflecting significant growth year over year. A potential approval for tisotumab vedotin will add a fourth drug to Seagen’s portfolio, which should drive growth for the company in 2021 and beyond.

Zacks Rank & Stocks to Consider

Seagen currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Nabriva Therapeutics AG (NBRV - Free Report) , 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.

Repligen’s earnings estimates have been revised 15.1% upward for 2021 and 9.8% upward for 2022 over the past 60 days. The stock has increased 7.5% year to date.

Nabriva’s loss per share estimates have narrowed 45.8% for 2021 and 50.9% for 2022 over the past 60 days.

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