Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging

Melbourne (Australia) and Indianapolis, IN (United States) | September 30, 2026

FDA Fast Track designation granted for Telix’s BiPASS® program, which is evaluating ⁶⁸Ga-PSMA-PET imaging alongside MRI in the pre-biopsy prostate cancer setting.
The designation recognizes the program’s potential to address an important unmet need by enabling an imaging-first approach to initial prostate cancer diagnosis.
Fast Track facilitates more frequent engagement with the FDA and may enable expedited review of the planned NDA.

Telix today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s BiPASS® program.

BiPASS (Biopsy of the Prostate Avoidance Stratification Study [1]) is evaluating gallium-68 (⁶⁸Ga) PSMA-PET imaging[2] in combination with MRI[3] for the detection of prostate cancer prior to biopsy.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need[4], potentially accelerating patient access if approved. More than three million prostate biopsies are performed globally each year[5], yet up to 75% produce a negative result[6]. Biopsy can be stressful and painful for patients and may provide no meaningful diagnostic benefit[7], highlighting the importance of improved diagnostic tools earlier in the patient journey.

Telix recently completed enrollment in the Phase 3 BiPASS study of its proprietary ⁶⁸Ga-PSMA-PET agents, Illuccix® (kit for the preparation of gallium Ga68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga68 gozetotide injection) for pre-biopsy prostate cancer diagnosis. The Company has positively engaged with the FDA on a new drug application (NDA) pathway and is planning its submission. The NDA pathway supports registration as a new product which, if approved, would broaden access to ⁶⁸Ga-PSMA-PET imaging for a substantially larger patient population.

BiPASS builds on the clinical foundation established by the PRIMARY[8] and PRIMARY2[9] studies. These studies demonstrated that combining ⁶⁸Ga-PSMA-PET imaging with MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent. BiPASS is not intended to replace biopsy when it benefits the patient but rather aims to improve the diagnostic pathway by helping clinicians determine which patients would benefit from biopsy and where biopsy should be targeted.

Dr. David N. Cade, Group Chief Medical Officer at Telix, said, “Fast Track designation reflects the FDA’s recognition of the potential for BiPASS to address an important unmet need in the prostate cancer diagnostic pathway. 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. This designation supports continued close engagement with the FDA as we advance BiPASS toward an NDA submission.”

Illuccix and Gozellix are approved for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, and in patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Illuccix is also approved for the selection of patients indicated for PSMA-directed therapy. The use of Illuccix and Gozellix in the pre-biopsy setting remains investigational and has not been approved by the FDA or any other regulatory authority.

About Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Illuccix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level, and for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
The safety of gallium Ga 68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).
Adverse reactions occurring at a rate of < 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

Injection site pain has been identified during post-approval use of ILLUCCIX.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please note that this information is not comprehensive.
Please see the Full Prescribing Information here.

About Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Hypersensitivity Reactions to Sulfites
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

Please note that this information is not comprehensive.
Please see the Full Prescribing Information here.

[1] ClinicalTrials.gov ID: NCT07052214.

[2] Imaging of prostate-specific membrane antigen with positron emission tomography.

[3] Magnetic resonance imaging.

[4] Visit: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

[5] Hu et al. JAMA Oncol. 2024.

[6] Vickers et al. J Clin Oncol. 2010.

[7] Durkan G et al. Prostate Cancer Prostatic Dis. 2000.

[8] Emmett et al., Eur Urol. 2021.

[9] Buteau et al. Lancet Oncol. 2026. ClinicalTrials.gov ID: NCT05154162.