News

– Data demonstrate that late dosing results in failure to maintain testosterone suppression to recommended levels for disease management –

CHICAGO – May 18, 2020 – Tolmar Pharmaceuticals Inc., a specialty pharmaceutical company, today announced publication in the April issue of the Journal of Urology of a real-world analysis of medical records of patients with prostate cancer treated with LHRH agonist therapies. The retrospective review evaluated the records of 22,860 patients with prostate cancer who were treated with LHRH agonists from January 2007 through June 2016 to further understand the impact of non-adherence to dosing schedules on testosterone (T) suppression levels. It also captured real-world data on these patients to assess the frequency of measurement of levels of T and prostate-specific antigen (PSA).

Androgen deprivation therapy (ADT) is the standard of care for patients with advanced prostate cancer. The goal of ADT is to reduce T to castration levelsand thereby inhibit the growth of malignant prostate cancer cells. The target level for castration has historically been set at 50ng/dL; however, increasing evidence suggests that levels of less than 20ng/dL are seen following surgical castration.[i] ADT is widely used to suppress levels of T in the blood in men with advanced prostate cancer.

Analysis Demonstrated Late Dosing Patterns, Limited Testosterone Testing

• 84% of injections were administered late with a 28-day month schedule, with 60% more than one week late and 29% more than two weeks late.
• Delays in injection timing were also frequent with extended month (a little longer than calendar months) schedules, which may be more representative of dosing in real-world clinical practice. 27% of injections were late, with 13% more than one week late and 9% more than two weeks late.
• T assessments were performed with only 13% of ADT injections, compared to 83% for PSA tests.

Impact on Testosterone Suppression

• Notably, with early/on time administration, only 4% of injections were associated with T levels >50ng/dL for both 28-day and extended month analyses. In contrast, when injections were administered late, 15% of tests for the 28-day month and 27% for the extended month showed T levels >50ng/dL.
• The impact of late dosing was especially pronounced when considering levels of T >20ng/dL. For the 28-day month, 31% of T levels >20ng/dL and 43% for the extended month.
• The greatest impact on T suppression was when dosing was more than two weeks late. For example, in the extended month analysis, half of T levels were >20ng/dL.

“These new real-world findings confirm that late injection of LHRH agonists is common in clinical practice along with infrequent measurement of levels of testosterone. This is concerning as men with advanced prostate cancer not receiving their ADT on time may experience inadequate testosterone suppression, which could adversely impact disease progression and survival,” said E. David Crawford, M.D., lead study author and Professor of Urology at the University of California, San Diego. “Our analysis underscores the importance of administering LHRH injections in a timely fashion and conducting more frequent testosterone testing to ensure target levels below 20ng/dL are achieved to reach the levels achieved with surgical castration.” 

Dr. Jason M. Hafron, M.D., study author and Partner at the Michigan Institute of Urology commented, “These data underscore how important it is for Advanced Prostate Cancer Care (APCC) pathways to include mechanisms that ensure patients receive their LHRH injections on time and that treatment effects are monitored with both testosterone and PSA tests. In the current environment of restrictions in the number of patient visits due to the COVID-19 pandemic, these data are particularly relevant. It should also be recognized that use of the longest acting doses of LHRH agonists, such as 6-month, would reduce the potential for delays in dosing.”

“As the manufacturer of the LHRH agonist Eligard^®, we are committed to collaborating with clinical experts to advance the science around the treatment of advanced prostate cancer,” said Dr. Stuart Atkinson, Vice President of Medical Affairs at Tolmar Pharmaceuticals. “This real-world, retrospective analysis of the medical records of nearly 23,000 patients who were treated with LHRH agonists for prostate cancer exemplifies how we hope to equip healthcare providers with relevant and timely information that may help inform their approach to delivering high-quality care.”

About ELIGARD

ELIGARD (leuprolide acetate) for injectable suspension is a prescription drug, given by injection, for the palliative treatment of advanced prostate cancer. ELIGARD is an LHRH agonist. ELIGARD uses a novel, polymeric gel, extended-release delivery technology that is designed to release leuprolide acetate at a controlled rate over an extended dosing period and enables subcutaneous administration. ELIGARD is available in 1-, 3-, 4- and 6-month dosing forms.

Important Safety Information

ELIGARD® is indicated for the palliative treatment of advanced prostate cancer. ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits. May cause fetal harm. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to the current clinical practice.

ELIGARD may impair fertility in males of reproductive potential.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported.

See package insert for full Prescribing and Safety Information or visit eligardhcp.com/PI.

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

About Tolmar Pharmaceuticals

Tolmar Pharmaceuticals, Inc., along with its affiliated companies, is a fully integrated pharmaceutical company focused on the innovative development, approval, manufacturing and commercialization of specialty pharmaceuticals. The Company's lead product, ELIGARD^® (leuprolide acetate) for injectable suspension, is a gonadotropin releasing hormone (GnRH) agonist indicated for the palliative treatment of advanced prostate cancer. Tolmar global headquarters, product development and manufacturing facilities are based in northern Colorado, while Tolmar Pharmaceuticals' U.S. commercial business is based in Buffalo Grove, Illinois. For more information about the company, please visit tolmar.com. Information about ELIGARD is available at eligardhcp.com. 

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