Delivering on the Promise: Telix Anticipates Demand for 68GA PSMA-11

When the US Food and Drug Administration (FDA) announced on Dec. 1, 2020, the approval of UCLA/UCSF sponsored Gallium 68 PSMA-11 (⁶⁸Ga PSMA-11), the first diagnostic based on PET imaging of prostate-specific membrane antigen (PSMA) for prostate cancer patients,¹ Telix Pharmaceuticals was already preparing for the anticipated increase in demand for gallium. A week prior, Telix announced the FDA had accepted the company’s New Drug Application for TLX591-Dx, a “cold kit” for diagnosis of PSMA using rapid preparation of⁶⁸Ga PSMA-11.

Once approved, TLX591-Dx may provide better access to PSMA diagnostic tests for prostate cancer patients who are not located in the vicinity of the University of California Los Angeles (UCLA) or the University of California San Francisco (UCSF).

“Congratulations to both UCLA and UCSF for this exciting news,” says Anthony (Tony) Zinno, Vice President of Operations for Telix Pharmaceuticals. “There has been tremendous effort and work to bring PSMA imaging to the market, and it has created great excitement and interest from the nuclear medicine community and healthcare providers. We now have a new imaging approach to detect cancer sooner as well as determine whether or not the cancer has spread to other parts of the body.”

Prostate cancer is the second-leading cancer cause of death among American men. In the US, approximately one in nine men will be diagnosed with prostate cancer during their lifetime and about 1 in 41 men will die from the disease.²  “While we have some very good diagnostic tools, it is thought that information about PSMA status will help advance the diagnosis and, potentially, also the treatment of males with prostate cancer,” Zinno adds.

Gallium Supply and Demand

The first⁶⁸Ga generator was developed in 1964 but had limited use. In 2000, a new generation of⁶⁸Ga generators became commercially available. The last ten years has seen a significant increase in demand for⁶⁸Ga used for diagnosis and treatment planning in support of Theranostics (a combination of the terms therapeutics and diagnostics). According to Zinno, the⁶⁸Ga generator manufacturers have been strategically planning for the incremental⁶⁸Ga demand created by⁶⁸GA PSMA-11.

As with any new medical products, there are concerns and questions regarding the availability of⁶⁸Ga PSMA-11, its reliability, and its adoption into clinical care. Zinno feels, these concerns are allayed by the fact that PSMA has been heavily studied – a PubMed search of “PSMA prostate cancer” results in more than 2,800 papers demonstrating routine utilization in compassionate-use, in several countries. “There is ample capacity to produce and supply gallium,” Zinno adds, “as there are a variety of sources starting with the current generator manufacturers.”

“We’ve been active for several months looking at historical use and projecting future demand, collaborating with the manufacturers, including raw material suppliers, to assure that everyone along the supply chain is well abreast of what we believe will happen – timelines, anticipation of volume demands and being prepared to serve the needs of the market,” Zinno says. “So, we’re very comfortable that there is an adequate supply of gallium.”

With cyclotron-produced gallium, Zinno anticipates a period of adjustment in capacity and production to accommodate the new isotope, as most cyclotrons are currently utilized for producing Fluorine-18 (mainly for the production of¹⁸F-FDG).

Emergence of Theranostics

Driving the increased demand for PSMA is that it can be used for “theranostics,” a term used to describe the combination of using one radioactive drug to identify (diagnose) and a second radioactive drug to deliver therapy to treat the main tumor and any metastatic tumors. In many ways, theranostics is the embodiment of precision medicine in cancer treatment that can improve survivability by reducing treatment side effects or delivering other therapeutic components.  Zinno says it’s one of the most impactful advancements he has seen in in the industry.

"There have been so many great developments in this (nuclear medicine) space that are in practice today, but nothing like theranostic developments,” he says. “Not only are you able to diagnose a patient’s disease state, but you are also able to treat it.

Beyond PSMA, Telix is also investing in development of other theranostic products, including isotopes for renal cell carcinoma and glioblastoma.   “What’s happening in the industry is creating a lot of opportunity for maximizing current assets and also for expanding the cyclotron network to meet the demand,” says Zinno.

As interest and demand grows, Telix has been forming partnerships and alliances within the supply chain – ranging from raw material suppliers to distributors to ensure those demands can be met.

“Quite frankly, we are feeling very comfortable because of the flexibility and the design of our products,” Zinno explains. “You can produce gallium in a cyclotron that can be used with our products or you can produce gallium from a generator that can be used with our products. So, we’re really excited about that because it gives the market the opportunity to choose the flexibility and the availability. With our other products, they will be based with other isotopes, more than likely, and certainly, we feel there's ample capacity that is being worked on today that will be in place prior to their arrival into the marketplace.” 

Reinforcing Telix’s commitment and support of the demand for⁶⁸GA PSMA-11, Chris Behrenbruch, co-founder and CEO of Telix Pharmaceuticals, adds that the company aims to be the global leader in disruptive precision oncology products in 2021. “Telix is committed to delivering on the promise of nuclear medicine to help cancer patients live longer and with a better quality of life,”

Although there may be concerns about gallium production as suppliers and distributors gear up to support nuclear medicine theranostics, US physicians will have a new tool in their arsenal to improve the diagnosis and treatment of prostate cancer.

References

1. FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer. US FDA press release. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-psma-targeted-pet-imaging-drug-men-prostate-cancer.
2. American Cancer Society. Key Statistics for Prostate Cancer. Available at: https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.

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