- The FDA accepted the submitting of a brand new drug utility (NDA) for TLX007-CDx.
- TLX007-CDx is a brand new and proprietary chilly package for the preparation of prostate-specific membrane antigen (PSMA)-PET imaging for prostate most cancers.
- The FDA has set a Prescription Drug Person Charge Act (PDUFA) goal motion date of March 24, 2025.
The NDA for TLX007-CDx has been accepted by the FDA for the preparation of PSMA-PET imaging for prostate most cancers. A PDUFA aim date of March 24, 2025, has been set.1
TLX007-CDx is a chilly package for the preparation of PSMA-PET imaging for prostate most cancers. TLX007-CDx makes use of gallium-68 (68Ga) that’s sourced from newer excessive exercise mills in addition to cyclotrons which might be powered by the ARTMS QUANTM Irradiation System and GE FASTlab stable and liquid goal manufacturing system.
If permitted by the FDA, the chilly package might allow using a PSMA imaging product with an prolonged distribution profile in contrast with the at the moment permitted 68Ga PSMA-PET imaging brokers.
prostate most cancers below the microscope: © heitipaves – inventory.adobe.com
“We have now seen fast adoption and geographic enlargement of PSMA-PET imaging with our first industrial product Illuccix®, and this submitting acceptance is a vital step in the direction of additional bettering fairness of entry and reinforcing our dedication to innovation in prostate most cancers to proceed to satisfy the wants of healthcare professionals and their sufferers. We now look ahead to working with the FDA to deliver TLX007-CDx to American males dwelling with prostate most cancers, together with these residing in underserved communities and areas the place entry to state-of-the artwork imaging stays restricted,” mentioned Christian Behrenbruch, PhD, managing director and group chief government officer of Telix, in a press launch.
With the NDA, the corporate plans to proceed to advance affected person entry to PSMA-PET imaging. It additionally goals to reinforce the scientific advantages of 68Ga imaging to affected person populations which might be underserved throughout the US via using nuclear pharmacy distribution partnerships and industry-leading on-time reliability established by Telix.
At present, TLX007-CDx has not obtained advertising authorization in any jurisdiction.
Beforehand in December 2021, 68Ga-PSMA-11 (Illuccix) was granted approval by the FDA.2 This package is for the preparation of 68Ga gozetotide injection in sufferers with prostate most cancers who’ve suspected metastasis and are candidates for preliminary definitive remedy. This approval can be supposed for sufferers with suspected recurrence based mostly on elevated serum prostate-specific antigen.
In March 2023, the FDA expanded the indication of 68Ga-PSMA-11 to incorporate sufferers with metastatic prostate most cancers indicated for 177Lu 177 PSMA-directed remedy.3 Additional, 68Ga-PSMA-11 is permitted in Canada and Australia.
REFERENCES
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FDA accepts Telix NDA for brand new prostate most cancers imaging agent. Information launch. Telix. July 24, 2024. Accessed July 24, 2024. https://tinyurl.com/pd4ktnn2
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FDA approves Telix’s prostate most cancers imaging product, Illuccix. Information launch. December 20, 2021. Accessed July 24, 2024. https://tinyurl.com/55swyyz8
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FDA approves expanded indication for Telix’s Illuccix to incorporate affected person choice for PSMA-directed radioligand remedy. Information launch. March 16, 2023. Accessed July 24, 2024. https://tinyurl.com/3edj3nb9
