Commercial-stage biopharmaceutical business Telix Pharmaceuticals (ASX: TLX) has moved a step closer to bringing to market its brain tumour imaging product known as Pixclara, after receiving ‘New Drug Application’ (NDA) status from the US Food and Drug Administration (FDA).
The company’s formal application has now been granted priority review by the FDA, with a commercial launch for Pixclara in the lucrative American market on track for next year.
Pixclara is an investigational imaging agent designed to enhance the diagnosis of aggressive brain tumours known as gliomas. It is utilised in positron emission tomography (PET) scans to help identify the disease in the brain.
There is currently no FDA-approved targeted amino acid PET agent for brain cancer imaging commercially available in the US. In turn, the FDA has designated Pixclara as an ‘orphan drug’ to fast-track its development, with an approval target date for the product now set for April 2025.
Formal authorisation from the FDA would open the door for commercialisation of Pixclara in the US market.
According to Telix, there exists a critical unmet need to improve the diagnosis and management of gliomas which represent the most common primary brain tumours of the central nervous system (CNS). They account for about 30 per cent of all brain and CNS tumours, and 80 per cent of all malignant brain tumours.
In particular, GBM is a high-grade glioma and the most common and aggressive form of primary brain cancer with about 22,000 new cases diagnosed in America each year.
Treatment of GBM involves surgery, which is then followed by combined radiotherapy and chemotherapy. However, recurrence of GBM occurs in almost all patients with an expected survival duration of between 12 and 15 months from first diagnosis.
Existing scanning methods for gliomas and GBM involve magnetic resonance imaging (MRI) techniques, which the company believes can lead to inconclusive results that delay treatment decisions when time is of the essence.
Telix chief executive officer, Kevin Richardson, said:
“Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the U.S., and bring it into line with a more advanced standard of care currently used in other markets. There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes.”
More broadly, Telix is developing a portfolio of clinical and commercial-stage products that seek to address significant unmet medical needs in the fields of oncology and rare diseases.
In December 2021, the company was granted FDA approval for its diagnostic imaging agent Illuccix, which is used in PET scans to help healthcare professionals detect prostate cancer in patients.
The milestone authorisation paved the way for the company’s first commercial launch in America with Illuccixx hitting the shelves in April 2022. By the end of the calendar year Telix had generated some $160 million in revenue, mainly stemming from Illuccix sales.
This momentum continued into 2023 with total revenue of $503 million soaring by 214 per cent from just twelve months earlier. Most recently, Telix reported that revenue in the first nine months of 2024 had already surpassed $565 million.
Overall, Telix is developing a broad portfolio of innovative products for the diagnosis of prostate, kidney, brain, and musculo-skeletal diseases. Management believes its total market opportunity in the US alone totals US$4.5 billion.
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