International Cancer Imaging Society

Monopar Provides Update on MNPR-101-Zr Radiopharma Clinical Trial

Retrieved on: 
Tuesday, February 27, 2024

“We are very excited to have Professor Hicks as the lead investigator for our MNPR-101-Zr clinical trial,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

Key Points: 
  • “We are very excited to have Professor Hicks as the lead investigator for our MNPR-101-Zr clinical trial,” said Chandler Robinson, MD, Monopar’s Chief Executive Officer.
  • In 2023, Professor Hicks received the Saul Hertz Award from the Society of Nuclear Medicine and Molecular Imaging for his lifetime contribution to radionuclide therapy.
  • “The preclinical data that Monopar announced on this past Thursday encourages us to translate this class of agents into the clinical domain.
  • MNPR-101-Zr is being developed for cancers with very high unmet medical need, such as pancreatic cancer and triple negative breast cancer,” said Professor Hicks.

Lantheus Announces Updates to the NCCN Guidelines for PSMA PET Imaging for Prostate Cancer

Retrieved on: 
Wednesday, May 11, 2022

A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.

Key Points: 
  • A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.
  • The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels.
  • Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET?
  • PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review.

Lantheus Announces Collaboration to Support Prostate Cancer Clinical Development

Retrieved on: 
Tuesday, March 29, 2022

About Prostate CancerProstate cancer is the second most common form of cancer affecting men in the United States -- an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2022, almost 268,500 new cases of prostate cancer will be diagnosed, and about 34,500 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.1

Key Points: 
  • A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.
  • PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues.
  • Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
  • PSMA-targeted radiotracers versus 18F fluciclovine for the detection of prostate cancer biochemical recurrence after definitive therapy: a systematic review and meta-analysis.

Palette Life Sciences Enters Into an Agreement with Lantheus to Support the Promotion of PYLARIFY® (Piflufolastat F18)

Retrieved on: 
Thursday, February 24, 2022

SANTA BARBARA, Calif. and STOCKHOLM, Sweden, Feb. 24, 2022 (GLOBE NEWSWIRE) -- Palette Life Sciences (“Palette”), a global medical device company dedicated to improving prostate radiation therapy outcomes, announced the signing of an Agreement with Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH) to support the promotion of PYLARIFY® (piflufolastat F 18) in the United States. PYLARIFY injection is a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence of recurrent and/or metastatic prostate cancer. PYLARIFY was approved by the U.S. Food and Drug Administration in May 2021.

Key Points: 
  • The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of 2% during clinical studies with PYLARIFY.
  • Palette Life Sciences is a fully integrated life sciences company.
  • Palette Life Sciences products improve patient outcomes in urology and urogynecology disorders, colorectal conditions, radiotherapy, and interventional oncology procedures.
  • Palette Life Sciences moves rapidly to leverage novel applications of existing technologies to create breakthrough medical solutions.

Lantheus Announces PYLARIFY AI™ is Now Available

Retrieved on: 
Monday, November 29, 2021

The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels.

Key Points: 
  • The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels.
  • The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of 2% during clinical studies with PYLARIFY.
  • PYLARIFY AI: A Novel Automated-PROMISE platform to Standardize Evaluation of Tumor Burden in (18)F-DCFPyL (PSMA) images of Veterans with Prostate Cancer.
  • Analytical performance of PYLARIFY AI: automated anatomic contextualization, detection, and quantification of [(18)F]DCFPyL (PSMA) imaging for standardized reporting.

Lantheus Announces CMS Grants Transitional Pass-Through Payment for PYLARIFY® (piflufolastat F 18) Injection, Effective January 1, 2022

Retrieved on: 
Monday, November 22, 2021

NORTH BILLERICA, Mass., Nov. 22, 2021 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that the Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through Payment Status for PYLARIFY® (piflufolastat F 18) injection effective January 1, 2022. Transitional Pass-Through Payment Status enables Medicare to provide an incremental payment for PET-CT scans done with PYLARIFY in the hospital outpatient setting.

Key Points: 
  • The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels.
  • PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues.
  • Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods.
  • The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of 2% during clinical studies with PYLARIFY.

Lantheus Holdings Announces Presentations Featuring PYLARIFY® (Piflufolastat F 18), its PSMA-Targeted Prostate Cancer Imaging Agent, at Key Scientific Meetings

Retrieved on: 
Wednesday, November 17, 2021

A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.

Key Points: 
  • A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.
  • The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels.
  • PYLARIFY uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues.
  • 4Werner et al 18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging Theranostics 2020; 10(1):1-16. doi:10.7150/thno.37894.

Lantheus Announces Addition of PSMA PET Imaging Agent to the National Comprehensive Cancer Network® (NCCN) Guidelines for Prostate Cancer

Retrieved on: 
Monday, September 13, 2021

A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.

Key Points: 
  • A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer.
  • The performance of PYLARIFY for imaging of patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels.
  • Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET?
  • PSMA PET for primary lymph node staging of intermediate and high-risk prostate cancer: an expedited systematic review.