Expanded FDA Approval Allows Use of Pluvicto Prior to Chemotherapy in Patients with mCRPC
Recent research demonstrated a 59 percent reduced risk of progression or death with the radioligand therapy Pluvicto in comparison to a change of androgen receptor pathway inhibitor (ARPI) for patients with metastatic castration-resistant prostate cancer (mCRPC).
The Food and Drug Administration (FDA) has granted expanded approval of the radioligand therapy 177Lu-PSMA-617 (Pluvicto®, Novartis) for patients with metastatic castration-resistant prostate cancer (mCRPC).
For patients with prostate-specific membrane antigen (PSMA) positive mCRPC, Pluvicto may be utilized for those who have received an androgen receptor pathway inhibitor (ARPI) and prior to the use of chemotherapy, according to Novartis.
For patients with prostate-specific membrane antigen (PSMA) positive mCRPC, the FDA has granted expanded approval of the radioligand therapy Pluvicto for those who have received an androgen receptor pathway inhibitor (ARPI) and prior to the use of chemotherapy. (Image courtesy of Adobe Stock.)
A recently published phase 3 trial revealed that Pluvicto, in comparison to a change of ARPI, reduced the risk of radiographic progression and death by 59 percent in this patient population.
Novartis added that the primary adverse events for patients treated with Pluvicto in the study were dry mouth (61 percent), fatigue (53 percent) and nausea (32 percent).
"This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy,” emphasized Michael Morris, M.D., the principal investigator of the study and prostate cancer section head at the Memorial Sloan Kettering Cancer Center in New York City.
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