Alpha Tau Receives FDA TAP Acceptance to Expedite Alpha DaRT for Recurrent Glioblastoma

Key Insights

• Alpha Tau Medical has been accepted into the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) to accelerate market access for Alpha DaRT in recurrent glioblastoma multiforme (GBM).
• The TAP program aims to expedite patient access to innovative medical devices by providing early and strategic communication with the FDA and facilitating engagement with key stakeholders.
• Alpha DaRT is designed for potent alpha-irradiation of solid tumors through intratumoral delivery of radium-224 impregnated sources, targeting tumor cells while sparing healthy tissue.

Alpha Tau Medical Ltd. has announced its acceptance into the U.S. Food and Drug Administration's (FDA) Total Product Life Cycle (TPLC) Advisory Program (TAP) to expedite market access for Alpha DaRT in patients with recurrent glioblastoma multiforme (GBM). This follows the company's previous receipt of Breakthrough Device Designation from the FDA for this indication.

Expediting Access to Innovative Therapies

The TAP program is designed to accelerate patient access to promising medical devices not currently on the market. It facilitates early, frequent, and strategic communications with the FDA and engagement with other key parties. A dedicated team of FDA TAP advisors provides tailored assistance in areas including product lifecycle regulation, payer coverage policies, and integration of patient insights.

"As Alpha Tau intensifies its ongoing focus on treating internal organs with tremendous unmet need, and advances further towards commercialization of the Alpha DaRT, this exciting announcement comes at exactly the right time," said Alpha Tau Chief Executive Officer Uzi Sofer. "With an estimated 14,000 new GBM diagnoses per year in the U.S., and exceedingly low five-year survival rates, the need to expedite access to new innovative therapies is clear."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors. It involves intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released and disperse while emitting high-energy alpha particles, with the goal of destroying the tumor. The alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Glioblastoma Multiforme (GBM)

Glioblastoma multiforme is one of the most aggressive and challenging cancers to treat. The acceptance into the FDA's TAP program represents a significant step forward in the development and potential commercialization of Alpha DaRT as a treatment option for patients with recurrent GBM, addressing a critical unmet need in oncology.