Full Press Release Details
Lantheus Holdings Announces Acceptance and Priority Review of New Drug Application for
PyLTM (18F-DCFPyL), a PSMA-Targeted Prostate
Cancer PET Imaging Agent
PDUFA action date of May 28, 2021 assigned by U.S. Food and Drug Administration
NORTH BILLERICA, MA., December 9, 2020 - Lantheus Holdings, Inc. (NASDAQ: LNTH) (the Company), the parent company of Lantheus Medical Imaging, Inc. and
Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced that the U.S. Food and Drug Administration (FDA) has accepted
the New Drug Application (NDA) for PyLTM (18F-DCFPyL), a prostate specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging agent
for prostate cancer.
The FDA granted Priority Review for the PyL NDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28,
2021. The FDA has also indicated in the NDA filing acceptance notification that it is not currently planning to hold an advisory committee meeting to discuss the application.
We are pleased that the FDA has accepted our PyL NDA for review and granted our application Priority Review, which is a significant milestone for
Lantheus. We believe that there is a significant unmet need for reliable, targeted imaging in prostate cancer, particularly in the high risk and biochemically recurrent populations, said Istvan Molnar, MD, Chief Medical Officer of Lantheus.
We look forward to working with the FDA during the NDA review process with the goal of bringing PyL to patients and physicians who need it.
The PyL NDA is supported by data from two Company-sponsored pivotal studies (OSPREY and CONDOR) designed to establish the safety and diagnostic performance of
PyL imaging across the prostate cancer disease continuum. Results from OSPREY Cohort A demonstrated improvement in specificity and positive predictive value (PPV) of PyL PET imaging over conventional imaging in men with high risk prostate cancer.
OSPREY Cohort B and CONDOR studied men with prostate cancer in various disease states, including biochemical recurrent, hormone sensitive, non-metastatic castrate resistant, and metastatic castrate resistant.
OSPREY Cohort B demonstrated the sensitivity of PyL PET imaging in detecting metastatic lesions, while CONDOR, in patients with biochemical recurrent prostate cancer and non-informative baseline findings,
demonstrated PyL s high correct localization rate and detection rate, including in patients with low PSA values. In the CONDOR study, 63.9% of patients had a change in intended disease management plans due to the PyL PET imaging results. We
believe the results from these two studies, taken as a whole, demonstrate the ability of PyL to reliably detect and localize disease and could enable more appropriate patient management.
PyL has been administered in approximately 3,500 subjects globally, including the two Company-sponsored
pivotal studies, multiple investigator sponsored studies, as well as clinical use reported in the literature. Across these studies, PyL has shown an attractive safety profile.
About PyL for PET Imaging of Prostate Cancer
PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables
visualization of localized prostate cancer as well as bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
The Phase 2/3 OSPREY trial assessed the
diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high risk, locally advanced prostate cancer (Cohort A) and distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). In the
trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% although the trial did not meet one of its the primary endpoints. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99%
and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.
The Phase 3 CONDOR trial evaluated the
diagnostic performance and clinical impact of PyL in men with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities. The CONDOR trial achieved its primary endpoint, with a correct localization
rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of subjects with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging
and/or changes in PSA levels following radiation therapy. 63.9% of subjects in the CONDOR trial had a change in intended disease management plans due to PyL imaging results, a key secondary endpoint of the trial. The changes to treatment management
plans due to the PyL results included salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage local therapy, and planned treatment to observation.
About Prostate Cancer
Prostate cancer is the second most
common form of cancer affecting men in the United States an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year 192,000 new cases of prostate cancer will be
diagnosed, and 33,000 men will die of the disease. Approximately 3.2 million men in the United States currently count themselves among prostate cancer survivors.1
About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development,
manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY
Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in
nuclear medicine procedures; AZEDRA for the treatment of certain rare neuroendocrine tumors; and RELISTOR for the treatment of
opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that
are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking
statements may be identified by their use of terms such as anticipate, believe, confident, could, estimate, expect, intend, may, plan,
predict, project, target, will and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could
cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved.
Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result
of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) a delay
in obtaining, or failure to obtain, a positive regulatory outcome from the FDA and other regulatory authorities for PyL; (ii) the Company s ability to successfully launch PyL as a commercial product; (iii) the market receptivity to
PyL as a new diagnostic agent; (iv) the safety and efficacy of PyL; (v) the intellectual property protection of PyL; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including
those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
Senior Director, Investor Relations
Director, Corporate Communications