Telix Pharmaceuticals Limited gains FDA Fast Track for BiPASS imaging

More frequent FDA consultations are available to Telix Pharmaceuticals Limited ASXTLX NASDAQTLX after the FDA granted BiPASS Fast Track status on Wednesday; shares traded at A$15.93, down 1.36 per cent, at 12:03 p.m. AEST in Sydney. The decision follows completion of enrollment in a 350-patient Phase 3 study on Sept. 2 and concerns an investigational use before prostate biopsy.

Telix plans to submit a new drug application for the proposed use of its gallium-68 PSMA PET imaging agents, Illuccix and Gozellix, alongside MRI before prostate biopsy. Its Sept. 30 release gives no date for the BiPASS readout or planned NDA submission, and the designation does not itself authorize the proposed use.

Telix is a Melbourne-based commercial radiopharmaceutical company with a global cancer imaging business and a late-stage therapeutic pipeline.

The FDA says Fast Track makes a program eligible for more frequent meetings and written feedback during development. It can allow rolling submission of completed NDA sections; priority review is available only if separate criteria are met. Telix says it has discussed an NDA pathway with the agency; its Sept. 30 release gives no assigned review deadline. A Fast Track designation does not establish the diagnostic performance of the proposed pre-biopsy use.

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Imaging Before Biopsy Remains Investigational

Illuccix and Gozellix already have U.S. approval for PET imaging of PSMA-positive lesions in men with prostate cancer and suspected metastasis or recurrence. The proposed pre-biopsy use would move the agents earlier in diagnosis, where Telix hopes imaging will help identify who needs tissue sampling and guide where it is taken.

The BiPASS trial listing identifies biopsy-naive men with suspected prostate cancer who are scheduled for a template biopsy as potential participants. Telix described the study as prospective and open-label across the United States and Australia in its Sept. 2 enrollment notice. The company has disclosed neither BiPASS diagnostic performance results nor trial safety findings in its Sept. 30 announcement.

Telix says the earlier PRIMARY and PRIMARY2 studies found that pairing PSMA PET with MRI could reduce unnecessary biopsies by almost 50 per cent while improving detection of clinically significant disease. Those findings are the rationale for BiPASS, whose own results still need to show how the approach performs in the registrational study.

"We believe gallium-68 PSMA-PET, used alongside MRI, could help physicians make more informed decisions before biopsy, improve diagnostic confidence and potentially reduce unnecessary invasive procedures for patients," Telix group chief medical officer David N. Cade said in the release.

Lantheus Sells a Related Prostate Imaging Agent

Telix's Sept. 30 release estimates that more than three million prostate biopsies take place worldwide each year and that up to 75 per cent are negative. The figures describe the procedure market Telix hopes to address; they are not efficacy findings from BiPASS.

Lantheus Holdings, Inc. NASDAQLNTH is a listed PSMA PET peer. Its FDA approval announcement of May 27, 2021, says PYLARIFY is authorized to image suspected metastasis or recurrence in men with prostate cancer. That established indication sits at a different point in care from Telix's investigational pre-biopsy proposal.

Telix's Sept. 30 release gives no date for the BiPASS readout, its next disclosed evidence milestone. The study's diagnostic performance will determine what evidence Telix can take into its planned NDA submission.