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
| Source: Alpha Tau Medical Ltd.
TAP’s primary goal is to expedite and enable patient access to innovative and highly promising medical devices which are not currently on the market by providing early, frequent, and strategic communications with the FDA, and by facilitating engagement with other key parties for developers of devices of public health importance, with an eye toward reducing the time, cost and uncertainty of patient access through reimbursement and commercial adoption following FDA authorization. To achieve this goal, a dedicated cadre of FDA TAP advisors are selected to provide tailored and solutions-focused assistance to advance these devices to market and patient access, and to offer their expertise in areas including product lifecycle regulation, payer coverage policies, industry experience, physician provider group or specialty society connectivity, 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. We are delighted to have been selected by the FDA and are hopeful that the guidance from this distinguished panel of advisors will be immensely valuable in crafting our GBM strategy for maximal impact in the commercial market for patients with such a devastating disease.”
About Alpha DaRT®
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since 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.