PLUVICTO™ receives positive recommendations from CADTH and INESSS for progressive PSMA-positive metastatic castration-resistant prostate cancer

• Health technology assessment (HTA) agencies reinforce the therapeutic value of PLUVICTO™ and need for new approaches to treat advanced prostate cancer
  
  
• Positive HTA recommendations for reimbursement are an important milestone towards public funding of this option to treat eligible patients in Canada

MONTREAL, July 10, 2023 /CNW/ - Novartis Pharmaceuticals Canada Inc. is pleased to announce that the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) and the Institut national d'excellence en santé et services sociaux (INESSS) have recommended PLUVICTO™ (lutetium (¹⁷⁷Lu) vipivotide tetraxetan injection) for public reimbursement.

CADTH and INESSS have recommended public reimbursement of PLUVICTO™ for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and meet certain conditions.

"The positive reimbursement recommendations by CADTH and INESSS are very positive news for individuals living with PSMA-positive mCRPC, and their loved ones," said Laurent Proulx, President and CEO of PROCURE. "Implementing public funding to accelerate access in all provinces to innovative treatment approaches will be critical as the highest unmet need is among those living with advanced disease. This is a step in the right direction to help fill this gap."

PLUVICTO™ was approved by Health Canada in August 2022 and is the first targeted radioligand therapy for the treatment of PSMA-positive mCRPC in Canada¹. The novel mechanism of action binds to target PSMA-positive cancer cells, delivering radiation treatment directly to those cells and nearby cells¹.

"Recognition of the clinical benefits of PLUVICTO™ by CADTH and INESSS help drive our commitment to reimagining cancer care with targeted radioligand therapy and is a testament to the value of this treatment in progressing mCRPC," said Andrea Marazzi, Country President, Novartis Pharmaceuticals Canada Inc. "Precision cancer treatment is positively transforming the way advanced prostate cancer is managed and we look forward to continuing to collaborate with all stakeholders to achieve timely access to this advancement across Canada."

The CADTH and INESSS recommendations for reimbursement of PLUVICTO^TM are supported by the results of the pivotal Phase III VISION trial which randomized patients with PSMA-positive mCRPC who received ¹⁷⁷Lu-PSMA-617 in addition to best supportive/best standard of care (BSC/BSoC) versus patients treated with BSC/BSoC alone.

Full details on reimbursement recommendations for PLUVICTO™, including clinical criteria and conditions, are available on the CADTH and INESSS websites.

About PLUVICTO^TM

PLUVICTO^TM (lutetium (¹⁷⁷Lu) vipivotide tetraxetan injection) is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have received at least one androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy¹. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)¹. After administration into the bloodstream, PLUVICTO^TM binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein¹. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and/or triggering cell death¹.

About Novartis

Novartis is reimagining medicine to improve and extend people's lives. We deliver high-value medicines that alleviate society's greatest disease burdens through technology leadership in R&D and novel access approaches. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. About 103,000 people of more than 140 nationalities work together to bring Novartis products to nearly 800 million people around the world. Find out more at https://www.novartis.com

Novartis in Canada employs approximately 900 people to serve the evolving needs of patients and the healthcare system and invests over $30 million in R&D yearly in the country. We pride ourselves on our commitment to diversity and inclusion. We are recognized as a Great Place to Work^®, and ranked among the Top 50 Best Workplaces™, 2022 Best Workplaces™ for Women, for Giving Back, and for Hybrid Work in Canada™. For more information, visit www.novartis.ca

About Advanced Accelerator Applications Canada Inc.

Advanced Accelerator Applications Canada Inc. (ADACAP), a Novartis company, specializes in targeted radioligand therapies and precision imaging radioligands for oncology indications. We are committed to transforming patients' lives by leading innovation in nuclear medicine. ADACAP has a legacy as a leader in radiopharmaceutical drugs for Positron Emission Tomography (PET) and Single-Photon Emission Computed Tomography (SPECT) diagnostic imaging. For more information, please visit: www.adacap.com

References
^{1.  Advanced Accelerator Applications USA, Inc. PLUVICTO™ Canadian Product Monograph. August 25, 2022}

Pluvicto is a trademark.

SOURCE Novartis Pharmaceuticals Canada Inc.

Media contacts: Aimee Sulliman, C&E Lead (Oncology), Novartis Pharmaceuticals Canada Inc., + 1 416 254-6450, E-mail: [email protected]