Seagen Inc.
SGEN
and its Japanese partner, Astellas Pharma Inc., announced the completion of submissions of two supplemental biologics license applications (sBLAs) to the FDA for Padcev (enfortumabvedotin-ejfv). One of the sBLA seeks to convert Padcev’s accelerated approval to regular approval in adult patients with locally advanced or metastatic urothelial cancer who were previously treated withplatinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The second submission requests an expansion of the current label to include 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.
Shares of the company have increased 34% in the past year compared with the
industry
’s growth of 12.6%.
The first application is based on data from the phase III EV-301 confirmatory study (NCT03474107).The study compared Padcevwith chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated withplatinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The study’s primary endpoint was the overall survival (OS) of patients treated with Padcev versus chemotherapy.
The second submission, for a label expansion in the United States, was based on results from the second cohort of EV-201 (NCT03219333). The pivotal phase II study is evaluating Padcev in patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but were not eligible for cisplatin. The study’s primary endpoint was the objective response rate.
We remind investors that in December 2019, the 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. Following this nod, Padcev became the first FDA-approved drug for treating the given patient population.
Padcev is an antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule expressed in many solid tumors.
Zacks Rank & Stocks to Consider
Seagen
currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector include
Acorda Therapeutics Inc.
ACOR
,
Atea Pharmaceuticals Inc.
AVIR
and
Clearside Biomedical Inc.
CLSD
. All carry a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Acorda’s loss per share estimates have narrowed from $9.66 to $7.91 for 2020 over the past 60 days.
Atea’s earnings per share estimates have increased from $3.53 to $3.70 for 2021 over the past 60 days. Shares of the company have increased 174.9% in the past year.
Clearside’s loss per share estimates have narrowed from 38 cents to 28 cents for 2021 over the past 60 days. Shares of the company have increased 25.3% in the past year.
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