Seattle Genetics, Inc. SGEN along with Japanese partner Astellas Pharma, Inc announced that the FDA has accepted the biologics license application (BLA) for investigational agent enfortumab vedotin. The company is seeking an approval of the candidate 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.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Mar 15, 2020.
In July this year, Seattle Genetics and Astellas Pharma submitted the BLA to the FDA for the accelerated approval of enfortumab vedotin.
The BLA was based on data from the first cohort of the phase II EV-201 study on enfortumab vedotin, presented at the annual meeting of the American Society of Clinical Oncology (ASCO) held in June.
Back then, data from the study showed that enfortumab vedotin rapidly shrank tumors, having achieved an objective response rate (ORR) of 44% in majority of the patients while complete responses (CR) were observed in 12% of the given subject population. The median duration of tumor response was 7.6 months.
Shares of Seattle Genetics have rallied 23.6% so far this year against the industry’s decline of 1.3%.
Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule, expressed in many solid tumors. If approved, the candidate will reduce the company’s heavy dependence on its sole marketed drug Adcetris.
It is important to note that a phase III confirmatory EV-301 study, which is currently underway, is likely to support global registrations of enfortumab vedotin.
Another phase I EV-103 study is investigating EV for treating patients with locally advanced/metastatic urothelial cancer in earlier-line settings including a combination study with Merck’s MRK PD-1/L1 inhibitor Keytruda (pembrolizumab) and platinum chemotherapy in newly diagnosed patients besides those cancer patients, who progressed from the initial stage of the disease.
Zacks Rank & Stocks to Consider
Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Amgen Inc. AMGN and NuCana PLC NCNA, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Amgen’s earnings estimates have been revised 2.9% upward for 2019 and 4.8% for 2020 over the past 60 days.
NuCana’s loss per share estimates have been narrowed 17.5% for 2019 and 16.7% for 2020 over the past 60 days.
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