|Seattle Genetics and Astellas Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer|
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Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
“The FDA Breakthrough Therapy Designation underscores the potential of
enfortumab vedotin as a meaningful treatment for patients with locally
advanced or metastatic urothelial cancer. Further, it supports our rapid
development plans for this ADC, including the ongoing pivotal study in
this patient population,” said
“Achieving Breakthrough Therapy Designation for enfortumab vedotin is
another step forward in our goal to bring an additional treatment option
to patients who need it most,” said
The Breakthrough Therapy Designation was granted based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs. Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with CPI therapy, EV-103 (NCT03288545). The companies are also evaluating enfortumab vedotin in other solid tumors, including ovarian and non-small cell lung carcinoma.
More information about the ongoing trials can be found at www.clinicaltrials.gov.
About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.
About the Astellas and Seattle Genetics Collaboration
Seattle Genetics Forward Looking Statement
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to the therapeutic
potential of enfortumab vedotin, its possible safety, efficacy, and
therapeutic uses and anticipated development activities including future
clinical trials and intended regulatory actions. Actual results or
developments may differ materially from those projected or implied in
these forward-looking statements. Factors that may cause such a
difference include the inability to show sufficient activity in the
clinical trials and risk of adverse events as enfortumab vedotin advance
in clinical trials even after promising results in earlier clinical
trials. In addition, as our drug candidates or those of our
collaborators advance in clinical trials, adverse events and/or
regulatory actions may occur which affect the future development of
those drug candidates and possibly other compounds using similar
technology. More information about the risks and uncertainties faced by
Astellas Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.
The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.