Alpha Tau Medical has been accepted into the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot, aimed at expediting market access for Alpha DaRT® to treat recurrent glioblastoma multiforme (GBM). This comes after Alpha DaRT received Breakthrough Device Designation from the FDA, a prerequisite for TAP entry. The TAP program provides early strategic support from FDA advisors to help developers bring innovative, high-need medical devices to patients more quickly. With an estimated 14,000 new GBM cases annually in the U.S. and limited effective treatments, Alpha Tau’s CEO, Uzi Sofer, expressed optimism that the TAP guidance will significantly impact Alpha DaRT’s market readiness, offering new hope to those with limited treatment options.
Alpha DaRT® delivers targeted alpha-irradiation to tumors, limiting damage to surrounding healthy tissue. Founded in 2016, Alpha Tau Medical is advancing this innovative therapy for broader application across solid tumors.
https://www.globenewswire.com/news-release/2024/10/21/2966203/0/en/Alpha-Tau-Announces-Acceptance-Into-FDA-s-Total-Product-Life-Cycle-Advisory-Program-to-Accelerate-Market-Access-to-Alpha-DaRT-for-Patients-with-Recurrent-Glioblastoma-Multiforme.htmlRead the full article for more details: https://www.globenewswire.com/news-release/2024/10/21/2966203/0/en/Alpha-Tau-Announces-Acceptance-Into-FDA-s-Total-Product-Life-Cycle-Advisory-Program-to-Accelerate-Market-Access-to-Alpha-DaRT-for-Patients-with-Recurrent-Glioblastoma-Multiforme.html