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Seagen's (SGEN) Combo Drug Expanded-Use sBLA Gets Priority Tag

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Seagen Inc.  and partner, Astellas Pharma, announced that the FDA has accepted their supplemental biologics license application (sBLA) for Padcev (enfortumab vedotin-ejfv) under priority review. The sBLA is seeking approval for the combination therapy of Padcev and Merck’s (MRK - Free Report) Keytruda (pembrolizumab) in the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC).

A decision from the regulatory body is expected on May 9, 2024. The FDA generally grants a priority review to drugs with the potential to treat a serious condition and make the treatment available to patients as early as possible. Subject to approval, the Padcev/Keytruda combo will become the first treatment option for cisplatin-eligible and ineligible patients.

The sBLA for the first-line use of the combo therapy in cisplatin-eligible patients was supported by positive results from Seagen’s phase III EV-302 study (also known as KEYNOTE-A39). Per the data readout, treatment with the combination regimen of Padcev and Merck’s Keytruda improved overall survival and progression-free survival with statistically significant and clinically meaningful results in previously untreated la/mUC patients compared with platinum-containing chemotherapy. 

In the EV-302 study, it was also observed that the safety profile of the combo therapy was consistent with previously reported studies of this combination. Furthermore, no new safety concerns were identified.

Year to date, shares of Seagen have surged 65.9% against the industry’s 23.2% fall. 

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We would like to remind the investors that in April 2023, the FDA granted accelerated approval to the Padcev/Keytruda combo for the treatment of adult patients with first and second-line metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The accelerated nod was based on encouraging results from SGEN’s early-to-mid-stage EV-103 study, which was announced in September 2022.

Seagen stated that if the sBLA for the Padcev/Keytruda combo is approved in the la/mUC indication, it will convert the accelerated approval of the combination to standard approval for all first-line la/mUC patients, expanding the indication to cisplatin-eligible patients.

La/mUC is a form of bladder cancer that has spread to surrounding organs, muscles, or other parts of the body. Per the company, approximately 82,290 people are diagnosed with bladder cancer in the United States in 2023. Urothelial cancer accounts for most of all bladder cancers, out of which 12% of cases are la/mUC.

Seagen recognizes the need for new innovative therapies for these patients, as chemotherapy has been the standard of care for more than 30 years, representing a high unmet medical need. Most la/mUC patients progress within nine months and are at risk of death.

SGEN’s Padcev was initially approved by the FDA in December 2019 on an accelerated basis for the treatment of patients with advanced/metastatic bladder cancer who had received treatment with both a checkpoint inhibitor (PD-1/PD-L1) and platinum-based chemotherapy.

At present, the company is simultaneously evaluating the Padcev/Keytruda combo in other forms of bladder cancer as part of its extensive program, evaluating this combination in multiple stages of bladder cancer.

The phase Ib/II EV-103 study is evaluating Padcev as a monotherapy or in combination with Keytruda and/or chemotherapy in first- or second-line settings in patients with la/mUC and muscle-invasive bladder cancer (MIBC).

Two phase III studies, EV-304 and EV-303, are also currently ongoing to evaluate the Padcev/Keytruda combo in MIBC. Currently, Seagen does not have any evidence for the proven safety and efficacy of the Padcev/Keytruda combo in second-line urothelial cancer and MIBC.

Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug and is approved for several types of cancer, accounting alone for around 40% of MRK’s pharmaceutical sales. Keytruda is presently approved to treat seven indications in earlier-stage cancers in the United States. Merck’s Keytruda is continuously growing and expanding into new indications and markets globally.

Seagen Inc. Price and Consensus

Seagen Inc. Price and Consensus

Seagen Inc. price-consensus-chart | Seagen Inc. Quote

Zacks Rank and Stocks to Consider

Seagen currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) and ADMA Biologics (ADMA - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA carries a Zacks Rank #2 (Buy) at present.

You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share has increased from 67 cents to 73 cents. During the same time frame, the estimate for Puma Biotech’s 2024 earnings per share has increased from 56 cents to 62 cents. Year to date, shares of PBYI have lost 7.8%.

PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.

In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 6 cents to 3 cents. The estimate for ADMA Biologics’ 2024 earnings per share is pegged at 16 cents. Year to date, shares of ADMA have lost 4.6%.

ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%. 

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