A new standard for the treatment of prostate cancer
On behalf of the German Cancer Research Centre (DKFZ), we supported clinical development of a radiopharmaceutical therapeutic that is now considered one of the most important elements in the treatment of prostate cancer.
The DKFZ contacted us in 2014 with a research project on a lutetium-based drug for the treatment of prostate cancer, and we got the worldwide exclusive license for the product. During the project, we developed the research idea into a market-ready therapeutic – and gradually discovered the huge potential of this compound for treatment.
What is special about ¹⁷⁷Lu-PSMA-617 is how cleverly it works: It is injected into the patient and specifically attaches itself to the prostate cancer cells – via binding to the so-called prostate-specific membrane antigen (PSMA). The lutetium-177 with its half-life of seven days then works like radiotherapy from the inside out – directly where the cancer is located.
As a subcontractor, our task was to develop the precursor in a first step. We then labelled the molecule with lutetium, developed the formulation, and established a production process. We conducted the phase I and phase II studies mainly on our own.
At that time in 2017, we looked for a partner and found one in Endocyte, which was subsequently acquired by Novartis. Together, we eventually led ¹⁷⁷Lu-PSMA-617 to market readiness and approval in Europe and the US in 2022.
We formulated the final product – as it is used in patients today. We established a process for mass production – including the necessary audits. For the phase III trial, for example, we produced the precursor in large quantities; for the approval in Europe, we produced 2000 doses on site.
We have also built our strength in logistics: we know how to deliver a radioactive pharmaceutical quickly in lead containers worldwide in accordance with national and international regulations.
In the case of ¹⁷⁷Lu-PSMA-617, almost all of our competences come into play: from the development of a precursor, labelling and formulation to the study, quality control, mass production and worldwide distribution under complex regulatory conditions. We handle all aspects in-house with our own teams.
Meanwhile, ¹⁷⁷Lu-PSMA-617 is an approved, successful therapeutic for prostate cancer patients, marketed by Novartis. At the time of approval, 25.000 patients worldwide had already been treated with it. Up to 60,000 patients per year are expected to be treated with ¹⁷⁷Lu-PSMA-617.
· Precursor development
· Formulation of the final product
· Establishment of a production process with corresponding audits
· Implementation of phase I and phase II studies
· Quality control
· Worldwide distribution under radiopharmaceutical regulations