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Seagen (SGEN) Gets Positive CHMP Opinion for Bladder Cancer Drug

The CHMP gives a positive opinion on, and recommends approval to Seagen's (SGEN) Padcev as a monotherapy for treating adult patients with locally advanced/metastatic urothelial cancer.

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This story originally appeared on Zacks

Seagen Inc. SGEN and partner Astellas Pharma Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to its an antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin). The CHMP recommended approval of Padcev as a monotherapy for the treatment of locally advanced or metastatic urothelial cancer in adult patients who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.

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The positive CHMP opinion was based on data from the phase III EV-301 study, which evaluated enfortumab vedotin versus chemotherapy in the given patient population. The study had a primary endpoint of overall survival.

The opinion will now be reviewed by the European Commission. If approved, Padcev will become the first ADC authorized for patients with advanced urothelial cancer in the European Union.

Shares of Seagen have declined 14.3% so far this year compared with the industry’s decrease of 19%.

Zacks Investment ResearchImage Source: Zacks Investment Research

We remind investors that in December 2019, FDA granted accelerated approval to Padcev for the treatment of patients with advanced/metastatic urothelial cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.

In July 2021, the FDA approved two supplemental biologics license applications (sBLA) seeking label expansion for Padcev.

The first sBLA approval converts Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second sBLA approval makes Padcev the first and only FDA-approved drug to treat patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are not eligible for cisplatin.

In the first nine months of 2021, Padcev generated sales worth $247.2 million, reflecting an increase of 61% year over year. The drug has witnessed a solid uptake since its launch. A potential label expansion of the drug is expected to cater to a broader market, which will boost its revenue prospects in the future.

Seagen is also investigating Padcev in combination with Merck’s MRK PD-L1 inhibitor, Keytruda in several mid-stage studies in first- and second-line metastatic urothelial cancer, as well as muscle invasive bladder cancer.

Merck’s biggest revenue generator, Keytruda, is approved for treating several types of cancer indications.The drug is also being studied for other types of cancer indication.

Zacks Rank & Stocks to Consider

Seagen currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. SRPT and Editas Medicine, Inc. EDIT, 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.

Sarepta Therapeutics’ loss per share estimates have narrowed 28.2% for 2021 and 24.4% for 2022, over the past 60 days.

Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.

Editas Medicine’s loss per share estimates have narrowed 13.4% for 2021 and 6.6% for 2022, over the past 60 days.

Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.



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