Seagen (SGEN) Gets Early FDA Nod for Tivdak in Cervical Cancer (Revised)

Seagen Inc. SGEN, along with its Danish partner Genmab A/S GMAB, announced that the FDA has granted accelerated approval to their investigational antibody drug conjugate (“ADC”), Tivdak (tisotumab vedotin-tftv), for the treatment of recurrent/metastatic cervical cancer in adult patients whose disease progressed on or after chemotherapy.

Following the FDA nod, Tivdak became the first and only approved ADC to address the given indication.

We note that the approval of Tivdak comes before the scheduled Prescription Drug User Fee Act action date of Oct 10, 2021.

In April 2021, the FDA accepted and granted priority review to the biologics license application (“BLA”) for Tivdak. In February 2021, the BLA was submitted to the FDA for the accelerated approval of Tivdak.

The BLA was based on data from the pivotal phase II innovaTV 204 study, which evaluated Tivdak as a monotherapy for the treatment of recurrent/metastatic cervical cancer. The FDA has approved Tivdak under its Accelerated Approval Program based on tumor response and the durability of the response.

However, the approval for Tivdak came with a boxed warning for ocular toxicity.

Shares of Seagen have declined 9.2% so far this year against the industry’s rise of 0.9%.

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Per the company, over 14,480 new cases of invasive cervical cancer are expected to be diagnosed in the United States in 2021 with 4,290 women dying from the disease. Hence, the approval for Tivdak should offer a new treatment option for the given patient population.

Seagen’s portfolio currently comprises of three marketed drugs, namely, Adcetris, Padcev and Tukysa, which are approved for different cancer indications. The company generated net product revenues of $649.9 million in the first six months of 2021, reflecting 48% growth year over year. The latest approval for Tivdak has now added 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 #3 (Hold). Better-ranked stocks in the biotech sector include Vertex Pharmaceuticals Incorporated VRTX and Spero Therapeutics, Inc. SPRO, 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.

Vertex’s earnings estimates have been revised 10.2% upward for 2021 and 7.3% upward for 2022 over the past 60 days.

Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022 over the past 60 days.

(We are reissuing this article to correct a mistake. The original article, issued on September 21, 2021, should no longer be relied upon.)

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