Seagen remained silent on the possibility of a buyout from Merck as they reported their fourth-quarter and full-year financial results Wednesday, leaving investors guessing as to their future.
Rather than dwelling on the current market conditions, the Washington-based biotech chose to focus on future label expansions and their promising pipeline. With the potential for a bright future ahead, the company is determined to stay one step ahead of the competition and remain a leader in the industry.
In 2023, Seagen is looking forward to several key data readouts and regulatory milestones from its four approved products: Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin-ejfv), Tukysa (tucatinib), and tivdak (tisotumab vedotin-tftv). As David Epstein, CEO of Seagen, pointed out on an investor call, the future of the company hinges on these developments.
Epstein announced that the company is taking a proactive approach to furthering its clinical development programs, with 10 potentially registrational studies in the works for their approved products. These studies span across various tumor types and promise to be a major step forward in this area of research.
In November 2022, Adcentris made a significant breakthrough by receiving FDA approval to treat pediatric Hodgkin lymphoma in patients aged two years and above with high-risk disease. This is a major step forward in improving the treatment options available for young patients battling this life-threatening illness.
A month ago, Adcetris achieved a major milestone when it succeeded in meeting the primary endpoint of its multi-part Phase II trial in classical Hodgkin lymphoma. The drug, when combined with Bristol Myers Squibb’s Opdivo (nivolumab), showed promising results that could potentially lead to a label expansion. This is a major step forward in the fight against Hodgkin lymphoma and a testament to the potential of Adcetris.
Seagen’s Adcetris just received FDA approval, making it the standard-of-care for seven different malignancies, including front-line Hodgkin lymphoma. With this new approval, the company has high hopes that the drug will reach blockbuster status by 2023.
AstraZeneca is setting its sights on Padcev, its bladder cancer therapeutic, with the aim of turning it into a blockbuster drug. By targeting earlier stages of the disease, including muscle- and non-muscle-invasive forms of bladder cancer, AstraZeneca hopes to expand the utility of Padcev and grow it into a strong franchise in this space.
The U.S. Food and Drug Administration (FDA) has granted priority review for Padcev’s accelerated approval application, a revolutionary first-line treatment for metastatic bladder cancer. In combination with Merck’s Keytruda (pembrolizumab), Padcev promises to provide an effective treatment to patients who are ineligible for cisplatin treatment. With a target action date of April 21, Padcev could revolutionize the way bladder cancer is treated.
Seagen’s Padcev has been approved to treat locally advanced or metastatic urothelial cancer, and the pharmaceutical company is continuing to conduct research on the drug’s potential to treat other conditions. Beyond bladder cancer, Padcev has the potential to revolutionize treatment for a variety of diseases.
Seagen is looking ahead to a big year for Tukysa, their best-in-class tyrosine kinase inhibitor approved for HER2-positive metastatic breast and colorectal cancer. As they prepare to launch the product in markets outside of the U.S., they are looking forward to making Tukysa available to more people who need it.
The FDA recently granted accelerated approval for a treatment targeting patients with previously treated RAS wild-type, HER2-positive metastatic colon cancer. This approval marks a significant step forward in the fight against this type of cancer and is a testament to the progress being made in the medical field.
Seagen is taking its capabilities to the next level with the launch of its innovative antibody-drug conjugate (ADC) product Tivdak, already approved as a second-line treatment for metastatic cervical cancer. The company is now aiming to expand Tivdak’s label to include head and neck cancer, presenting a major growth driver for 2023. With this revolutionary treatment, Seagen is making strides in advancing cancer care.
Seagen is continuing to expand its product portfolio with the development of three promising ADC candidates. Disitamab vedotin is being developed to treat HER2+ metastatic urothelial cancer and other HER2-expressing solid tumors, while SGN-B6A and SGN-B7H4V target integrin beta-6 and the B7-H4 immune checkpoint protein respectively. These three products are set to join the four approved ADC therapeutics currently in Seagen’s portfolio, providing the potential for long-term growth.