Novartis awarded Promising Innovative Medicine designation for targeted radioligand theragnostics in prostate cancer

• The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted ¹⁷⁷Lu-PSMA-617 Promising Innovative Medicine (PIM) designation for metastatic castration-resistant prostate cancer.

• ⁶⁸Ga-PSMA-11, a targeted positron emission tomography (PET) imaging tracer was also given PIM designation, making it the first diagnostic imaging tracer to receive this status from the MHRA. 

• Prostate cancer causes over 11,500 deaths in the UK alone each year¹ and men with advanced prostate cancer have high unmet need regarding quality of life and symptom control²

• This recognition from the MHRA is an indication that ¹⁷⁷Lu-PSMA-617 and ⁶⁸Ga-PSMA-11 are promising candidates for the Early Access to Medicines Scheme (EAMS), aiming to provide equitable access to care for those with high unmet need.

London, UK. 23 September 2021 — Novartis today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Promising Innovative Medicine (PIM) designation for ¹⁷⁷Lu-PSMA-617, an investigational radioligand therapy (RLT) for the treatment of adult patients with prostate-specific membrane antigen (PSMA) positive metastatic prostate cancer.

The MHRA also issued PIM designation to ⁶⁸Ga-PSMA-11 for the diagnosis of PSMA positive lesions by positron emission tomography (PET) in patients with prostate cancer, making it the first diagnostic imaging tracer to receive PIM designation in the UK.

PIM designation is an early indication that medicinal products, such as ¹⁷⁷Lu-PSMA-617 and ⁶⁸Ga-PSMA-11, are promising candidates for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with unmet medical need. EAMS provides an opportunity for important therapies to be used in UK clinical practice in parallel with the later stages of the regulatory process.

“Prostate cancer takes the lives of approximately 11,500 each year in the UK¹ and sadly we know that men with advanced prostate cancer currently have limited treatment options,” said Alessandra Dorigo, General Manager of Advanced Accelerator Applications, UK & Ireland, Baltics and Nordics, a Novartis company. “This decision is highly encouraging for the patient community and is yet another example of the UK bringing innovative therapies to those who need them most. At AAA, a Novartis company, we understand that we must collaborate like never before to bring bold solutions to the NHS and UK patients. We look forward to working with the entire health system to provide treatments that are aligned to the priorities in the Long-Term Plan while delivering for people with cancer through targeted radioligand theragnostics, no matter where they are from or what their background.”

For the MHRA to grant a PIM designation, products must meet each of the following three criteria:

• High unmet need: The conditions should be life-threatening or seriously debilitating with high unmet need, meaning there is no method of treatment, diagnosis or prevention available, or existing methods have serious limitations.

• Significant advantage over current methods used: The medicinal product is likely to offer major advantage over methods currently used in the UK. Preliminary evidence should be submitted based on both non-clinical and clinical data.

• Positive benefit-risk balance: The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit risk balance.

Dr Gerhard Compion, Medical Lead at AAA, a Novartis company, said, “As prostate cancer is the most common cancer for males in the UK,³ and those with metastatic prostate cancer have a five-year survival rate of 30%,⁴ there is urgent need for new treatment and diagnostic options. This designation from the MHRA is an important milestone as it recognises the life-threatening nature and high unmet need of the advanced form of this disease. We will look to work with regulatory bodies as soon as possible to ensure as many patients can benefit from these potentially life-saving solutions.”

Plans to submit ¹⁷⁷Lu-PSMA-617 to relevant UK regulatory bodies later this year are underway, further supporting the company’s bold ambition to reach 1 million patients by 2030.