Seattle Genetics, Inc. (SGEN - Free Report) along with Japanese partner Astellas Pharma, Inc announced that the FDA has granted accelerated approval to its pipeline candidate Padcev (enfortumab vedotin-ejfv). The drug is approved 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.
Padcev is an antibody-drug conjugate (ADC) targeting Nectin-4, a cell adhesion molecule, expressed in many solid tumors. Following this nod, Padcev becomes the first FDA approved drug for treating the given patient population.
We remind investors that the approval comes much before the scheduled Prescription Drug User Fee Act (PDUFA) action date of Mar 15, 2020. The biologics license application (BLA) for Padcev was also granted a priority review by the FDA.
Shares of Seattle Genetics were up 6.1% in after-hours trading following this news on Wednesday. In fact, the stock has soared 99% so far this year compared with the industry’s increase of 8.5%.
While the accelerated approval for this indication was granted on the basis of tumor response rate observed in the phase II EV-201 study, a continued approval of the same may be contingent upon verification and description of clinical benefits in a confirmatory study.
Results showed that Padcev rapidly shrank tumors, achieving an objective response rate (ORR) of 44% among majority patients while complete responses (CR) were observed in 12% of the given patient population. The median duration of tumor response was 7.6 months.
This approval for Padcev should reduce Seattle Genetics’ heavy dependence on its sole marketed drug Adcetris and significantly boost the top-line growth in future quarters.
Meanwhile, earlier this month, Seattle Genetics and Astellas signed a collaboration agreement with pharma giant Merck (MRK - Free Report) to begin a phase III study for evaluating the combination of Padcev and the latter’s PD-1/L1 inhibitor Keytruda (pembrolizumab) to address patients with previously untreated metastatic urothelial cancer.
The study led by Seattle Genetics is expected to be conducted in the first half of 2020. It is likely to support global registrations of enfortumab vedotin.
In a separate press release, Seattle Genetics announced that the FDA has granted Breakthrough Therapy designation to its oral tyrosine kinase inhibitor tucatinib in combination with Roche's (RHHBY - Free Report) Herceptin (trastuzumab) and Xeloda (capecitabine) to treat patients with locally advanced/metastatic HER2-positive breast cancer including those with brain metastases and earlier being treated with Herceptin, pertuzumab and T-DM1.
The Breakthrough Therapy status is granted to accelerate the development and review of the drugs that target serious or life-threatening conditions.
The prestigious tag to tucatinib is based on data from the pivotal HER2CLIMB study, which evaluated the combo of tucatinib and Herceptin plus Xeloda as compared to Herceptin plus Xeloda for treating patients with locally advanced unresectable or metastatic HER2-positive breast cancer.
Seattle Genetics plans to submit a new drug application to the FDA and a marketing authorization in Europe for tucatinib by the first quarter 2020.
Zacks Rank & Key Pick
Seattle Genetics currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 58.8% year to date.
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