The Swiss based Pharma Major scores yet another FDA approval for its new radioligand therapy. This much anticipated regulatory nod was received this week, enabling the global innovator to offer a new treatment paradigm. mCRPC is the short form for metastatic castration resistant prostate cancer. Prostate cancer is the most common cancer type in men. An estimated number of over forty-five thousand men are diagnosed with this type of cancer every year. In the US alone one in forty-one men die of this malignancy. Given this scenario, every treatment intervention counts and every new innovation has its own immense value. Pluvicto is indeed the first radioligand therapy approved in this setting. The FDA approval is precise and specific to progressive, PSMA positive metastatic castration-resistant prostate cancer treatment. Pluvicto is also the second radiopharmaceutical treatment by Novartis to secure the FDA approval. Lutathera was the first and it is indicatedto treat neuroendocrine tumors.
Pluvicto significantly improved survival rates in the eligible mCRPC patients
Significant improvement in the overall survival was the key parameter that demonstrated the superiority of Pluvicto. This was based on the Phase III VISION trial outcomes that involved a total of 831 patients. It was a randomized (2:1), multicenter, open-label trial that compared Pluvicto plus best standard of care with best standard of care alone. 15.3 months of median overall survival was demonstrated in 551 patients who underwent treatment with Pluvicto. This was significantly high when compared with 11.3 months of median overall survival in patients that received BSoC alone. Radioligand therapies have a unique mechanism of action. They are developed by a combination of tumour targeting compound and radioactive therapeutic element. In the context of prostate cancer treatment, the tumour targeting compound binds with the PSMA expressing cancerous cells while the therapeutic agent kills the targeted cells with radioactive emissions. This unique mechanism of action helps in the targeted elimination of cancerous cells.
Available treatment modalities for mCRPC management
Treating localized prostate cancer with definitive treatments is known in the medical oncology practice. However, treating the advanced stage cancer diagnosed as metastatic castration resistant prostate cancer is challenging. There are different classes of drugs available that include chemotherapy agents, androgen synthesis inhibitors and androgen signal blockers. The recent research has provided some headway in terms of PSMA targeting. PSMA is nothing but the Prostate-specific Membrane Antigen. PSMA imaging or scan is used to assess the biochemical recurrence of the prostate cancer. This is highly relevant in pre-treated patients. PSMA-positive mCRPC is now considered as a well-defined prostate cancer setting. The role of Pluvicto is clearly established in this setting for which the approval was granted. Best supportive care would have been the only option in the absence of treatment with such radioligand therapy. This clearly establishes the significance of its overall survival outcomes as demonstrated in the Phase III VISION trial.
