This section highlights FDA-related milestones and regulatory updates for drugs developed by Lantheus (LNTH).
Over the past two years, Lantheus has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
177Lu-PNT2002, Lu-PNT2002, Piflufolastat, and PYLARIFY. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
177Lu-PNT2002 FDA Regulatory Events
177Lu-PNT2002 is a drug developed by Lantheus for the following indication: PSMA-targeted 177Lu-based radiopharmaceutical therapy that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- 177Lu-PNT2002
- Announced Date:
- August 20, 2024
- Indication:
- PSMA-targeted 177Lu-based radiopharmaceutical therapy that combines a PSMA-targeted ligand, PSMA-I&T, with the beta-emitting radioisotope no-carrier-added 177Lu.
Announcement
Lantheus Holdings, Inc. announced that Oliver Sartor, MD, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic in Rochester, Minnesota, will deliver an oral presentation, including additional clinical data from PNT2002's initial December 2023 readout, during the European Society of Medical Oncology (ESMO) Annual Meeting in Barcelona on Sunday, September 15, 2024.
AI Summary
Lantheus Holdings, Inc. announced that Oliver Sartor, MD, Director of Radiopharmaceutical Trials and Professor of Medical Oncology at the Mayo Clinic, will deliver an oral presentation at the European Society of Medical Oncology (ESMO) Annual Meeting in Barcelona on Sunday, September 15, 2024. In his talk, Dr. Sartor will share additional clinical data from the initial December 2023 readout of PNT2002, a promising radioligand therapy candidate for treating metastatic castration-resistant prostate cancer. The presentation, titled “Efficacy of 177Lu-PNT2002 in PSMA-positive mCRPC following progression on an androgen-receptor pathway inhibitor (ARPI) (SPLASH),” highlights further insights into how 177Lu-PNT2002 works in patients whose disease has progressed after using androgen-receptor pathway inhibitors. This new clinical data aims to bolster the potential of PNT2002 in addressing unmet needs in prostate cancer treatment.
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Lu-PNT2002 FDA Regulatory Events
Lu-PNT2002 is a drug developed by Lantheus for the following indication: In PSMA-Positive Metastatic Castration-Resistant Prostate Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Lu-PNT2002
- Announced Date:
- September 15, 2024
- Indication:
- In PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
Announcement
Lantheus Holdings, Inc. presented additional clinical data from initial topline results of the SPLASH Phase 3 trial evaluating the efficacy of 177Lu-PNT2002, a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), administered at 6.8 GBq every 8 weeks for up to 4 cycles in patients with metastatic castration-resistant prostate cancer (mCRPC) following progression on androgen receptor pathway inhibitor (ARPI).
AI Summary
Lantheus Holdings, Inc. recently presented important clinical data from the SPLASH Phase 3 trial during the ESMO Congress 2024 in Barcelona. The study evaluated the use of 177Lu-PNT2002, a PSMA-targeted radioligand therapy (RLT), given at 6.8 GBq every 8 weeks for up to 4 cycles to patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed on androgen receptor pathway inhibitors (ARPI). The trial met its primary endpoint by significantly extending radiographic progression-free survival, with treated patients experiencing a median of 9.5 months compared to 6.0 months in the ARPI control arm. Additional benefits included a higher overall response rate and improved quality of life. These early results indicate that 177Lu-PNT2002 could offer a promising treatment option for mCRPC patients who have limited alternatives after ARPI therapy.
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Piflufolastat F 18 (formerly 8F-DCFPyL) FDA Regulatory Events
Piflufolastat F 18 (formerly 8F-DCFPyL) is a drug developed by Lantheus for the following indication: Biochemically Recurrent Prostate Cancer (CONDOR).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Piflufolastat F 18 (formerly 8F-DCFPyL)
- Announced Date:
- August 6, 2025
- Indication:
- Biochemically Recurrent Prostate Cancer (CONDOR)
Announcement
Lantheus Holdings, announced that the Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent filed by its affiliate, Aphelion.
AI Summary
Lantheus Holdings, through its affiliate Aphelion, announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for a new formulation of its F 18 PSMA imaging agent. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s review goal date is set for March 6, 2026.
This new formulation is designed to increase batch size by roughly 50%, which means more doses per production run. By optimizing the manufacturing process and raising radioactive concentration, Lantheus aims to enhance supply resilience and expand geographic access to PSMA PET imaging. The agent builds on the performance of PYLARIFY, its current market‐leading PSMA PET tracer that boasts an 86% median true‐positive rate in detecting recurrent prostate cancer.
Company leaders say the streamlined process will support timely diagnostic imaging, help clinicians detect prostate cancer earlier, and better meet growing patient needs across the U.S. If approved, the formulation may deliver consistent efficacy while serving significantly more patients.
Read Announcement- Drug:
- Piflufolastat F 18 (formerly 8F-DCFPyL)
- Announced Date:
- August 6, 2025
- Estimated Event Date Range:
- March 6, 2026 - March 6, 2026
- Target Action Date:
- March 06, 2026
- Indication:
- Biochemically Recurrent Prostate Cancer (CONDOR)
Announcement
Lantheus Holdings, announced that The FDA has set an action date goal of March 6, 2026 under the Prescription Drug User Fee Act (PDUFA).
AI Summary
Lantheus Holdings, a leading radiopharmaceutical company, announced that the U.S. Food and Drug Administration has accepted a New Drug Application for its new F-18 PSMA imaging agent and set a Prescription Drug User Fee Act decision date of March 6, 2026. This new formula is filed by its affiliate, Aphelion.
This formulation aims to increase batch size by about 50%, boosting supply resilience and patient access. It maintains the same proven efficacy as PYLARIFY, which shows an 86% true-positive rate in studies of recurrent prostate cancer. Higher radioactive concentration also allows expansion into new geographic areas.
Brian Markison, CEO of Lantheus, said the updated agent marks a key step in improving prostate cancer imaging. Paul Blanchfield, president of Lantheus, added that optimizing production will streamline operations and help the healthcare system deliver fast, accurate diagnostic scans.
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PYLARIFY (piflufolastat F 18) FDA Regulatory Events
PYLARIFY (piflufolastat F 18) is a drug developed by Lantheus for the following indication: Metastasis or recurrence of prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PYLARIFY (piflufolastat F 18)
- Announced Date:
- February 5, 2025
- Indication:
- Metastasis or recurrence of prostate cancer
Announcement
Lantheus Holdings, announced piflufolastat F 18 data will be presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, taking place February 13-15, 2025, in San Francisco, CA.
AI Summary
Lantheus Holdings announced that data on its piflufolastat F 18 will be presented at the 2025 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium. The event will be held in San Francisco, CA, from February 13-15, 2025. This data presentation focuses on the diagnostic performance of piflufolastat F 18, also known as 18F-DCFPyL or PYLARIFY, a PET imaging agent used to detect recurrent and metastatic prostate cancer.
The symposium will feature two sessions on February 13, 2025. One session, presented by Ida Sonni from the University of California, will detail the early detection of recurrent prostate cancer using 18F-DCFPyL PET/CT in patients with minimal PSA levels. In the other session, Neal Shore will share preliminary observations from the PYLARIFY registry, highlighting how conventional imaging and piflufolastat F 18 work together in diagnosing both new and recurrent cases of prostate cancer.
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