Prostate cancer RLT therapy has promising prospects! Novartis AG's Pluvicto is expected to take the lead

According to the Smart Finance APP, the market for Radioligand Therapy (RLT) is expected to achieve significant growth by 2030, with Novartis AG's RLT product Pluvicto poised to capture the largest share in the field of prostate cancer therapy.

Prostate cancer is diagnosed most frequently among men in over half of the countries worldwide. The incidence and mortality rates of prostate cancer remain high. A major report on prostate cancer by The Lancet indicates that the global number of prostate cancer cases is projected to increase from 1.4 million annually in 2020 to 2.9 million annually in 2040, doubling the number of affected individuals. The largest increase is expected in low- and middle-income countries. It is estimated that the annual global deaths from prostate cancer will rise from 375,000 in 2020 to nearly 700,000 in 2040, representing an increase of approximately 85%.

RLT is a novel method of cancer treatment that utilizes specific molecules combined with radioactive isotopes to precisely target tumor lesions and use radiation to kill target cells. In recent years, innovative Radioligand Therapy (RLT) represented by Lutetium-177 has become a focus in the diagnosis and treatment of prostate cancer. This therapy has demonstrated its efficacy and safety in the treatment of gastroenteropancreatic neuroendocrine tumors and prostate cancer, particularly in improving the survival rate of patients with advanced metastatic prostate cancer.

According to data from GlobalData, Pluvicto (177Lu-PSMA-617) approved by the U.S. Food and Drug Administration (FDA) in 2022 is rapidly becoming the mainstream RLT product for prostate cancer. Pluvicto achieved $980 million in sales revenue in 2023, a 260% increase, positioning it just a step away from becoming a $1 billion "blockbuster" drug. By 2024, Pluvicto's sales revenue is expected to soar to over $1.5 billion, reaching around $4.3 billion by 2030.

Although Pluvicto is not the first RLT therapy approved for prostate cancer—Bayer's Xofigo (radium-223 dichloride) was approved in the U.S. in 2013, the revenue of Xofigo compared to Pluvicto appears insufficient. GlobalData predicts that Xofigo's sales revenue will only reach $244 million in 2024, decreasing to $161 million by 2030. However, Bayer collaborated with Bicycle Therapeutics (BCYC.US) in May 2023 to develop new radiopharmaceuticals, which is expected to offer more RLT therapies.

Thomas Wales, an oncology and hematology analyst at GlobalData, stated that Pluvicto's strong trial results will drive its growth. Pluvicto was approved by the FDA for marketing in March 2022 for adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are positive for prostate-specific membrane antigen (PSMA) and have received androgen receptor pathway inhibitors (ARPI) and taxane chemotherapy. The approval of Pluvicto was based on a pivotal Phase III clinical trial (VISION), which showed that adding Pluvicto to standard treatment significantly extended radiographic progression-free survival (rPFS) in advanced PSMA-positive mCRPC patients Thomas Wales added that Novartis AG recently submitted an application to expand the indication of Pluvicto to patients who have not received paclitaxel chemotherapy. If approved, this application will expand the potential patient market.

Other pharmaceutical companies are also developing RLT therapies for prostate cancer, which are expected to be launched in the coming years. This includes Eli Lilly's lutetium Lu 177 dotatate, which is expected to be approved by 2025. GlobalData estimates that lutetium will generate sales of only $125 million in 2025, increasing to $1.65 billion by 2030. In addition, Eli Lilly acquired radiopharmaceutical company POINT BioPharma for $1.4 billion in 2023, which is developing clinical and preclinical RLT therapies for cancer treatment.

AstraZeneca acquired Fusion Pharma for $2.4 billion to obtain the prostate cancer RLT candidate drug FPI-2265-202, a purchase that was completed earlier in 2024. Although the Phase 2/3 trial plan for this candidate drug targeting PSMA-positive mCRPC patients is expected to be completed by 2026, GlobalData predicts that the therapy will be approved in 2028, with sales revenue reaching only $182 million by 2030