Novartis AG is building out a new commercial footprint and expanding its internal manufacturing capacity ahead of an important launch in prostate cancer as the company looks to strengthen one of its four key oncology pillars – radioligand therapy.
The company announced the US Food and Drug Administration approval of Pluvicto (lutetium Lu 177 vipivotide textraetan) on 23 March for the treatment of adult patients with metastatic prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC). These patients have already been treated with androgen receptor inhibitors and taxane-based chemotherapy
Radiopharmaceutical Backgrounder
Radiopharmaceuticals are radioactive isotopes that can be used as diagnostic or therapeutic agents, and build on previous radiation oncology by being delivered to cancer cells either directly or using delivery vehicles in a targeted therapy approach. Targeting radiation at the cellular level has the potential to reduce side effects and enable even minute deposits of cancer cells to be killed throughout the body. In comparison to other systemic cancer treatment, radiopharmaceutical therapy has shown efficacy with minimal toxicity. Common side effects such as alopecia or peripheral neuropathy are generally less severe than seen with chemotherapy. Responses typically do not require prolonged treatment durations and are often observed after a single or at most five injections.
As of March 2022, Trialtrove identifies 1,104 trials that involve a radiopharmaceutical-based treatment. There are currently 21 ongoing or planned industry-sponsored Phase III trials; Novartis leads the way with four ongoing Phase III trials, ahead of Bayer and Cellectar Biosciences (three each)
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