US EditionFDA OKs Novartis Prostate Cancer Treatment, Triples Eligible Patient Pool - Novartis (NYSE:NVS)
- On Friday, the FDA approved Novartis' Pluvicto for expanded use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer patients who have already been treated with an androgen receptor pathway inhibitor .
- The approval addresses the need for earlier effective therapies, as approximately half of mCRPC patients do not live long enough to receive a second treatment, and treatment guidelines recommend avoiding multiple ARPIs.
- The Phase III PSMAfore trial data, with a data cutoff of February 2024, demonstrated that Pluvicto reduced the risk of radiographic progression or death by 59% and more than doubled median radiographic progression-free survival compared to switching to another ARPI.
- According to Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, "The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC," and Victor Bultó, President US of Novartis, stated, "Today's approval for an expanded indication for Pluvicto brings more choice to nearly three times as many patients, enabling us to further establish radioligand therapies as a pillar in cancer care."
- The expanded indication triples the number of patients eligible for Pluvicto, and Novartis, which acquired Pluvicto through the acquisition of Endocyte six years ago, has multiple RLT manufacturing facilities in the U.S. To meet the increased demand, expecting sales to reach over $5 billion annually.
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The Berkshire Eagle+20 Reposted by 20 other sources
FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer
New indication approximately triples eligible patient population, allowing Pluvicto® to be used after one androgen receptor pathway inhibitor (ARPI) and now before chemotherapyPluvicto significantly reduced risk of progression or death by 59% and more than doubled median radiographic progression-free survival…
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