New drug for prostate cancer patients approved
Pluvicto is for use in adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.
What you need to know:
- Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is for use in adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC).
- The regulator's approval marks a key clinical achievement for people with progressing mCRPC, who would otherwise have no alternative forms of treatment.
The United States Food and Drug Administration (FDA) has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a proposed drug for adults with prostate cancer that has already metastasised to other body parts.
The drug is the first FDA-approved targeted radio ligand therapy (RLT) that combines a targeting compound with a therapeutic radioisotope and is expected to be available to patients and physicians in coming weeks.
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is for use in adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC).
“This approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients," Dr Susanne Schaffert, president of Novartis Oncology, announced.
According to experts, these patients have already undergone taxane-based chemotherapy and androgen receptor pathway inhibition without success.
The regulator's approval marks a key clinical achievement for people with progressing mCRPC, who would otherwise have no alternative forms of treatment.
The five-year survival rate for patients is only around 15 per cent, indicating the urgency of a more stable form of therapy.
Jamie Bearse, chief executive officer and president of ZERO – The End of Prostate Cancer in an official statement said that the approval of Pluvicto offers new hope to the mCRPC community.
“Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients."
Apart from Pluvicto, the FDA also approved Locametz, the kit needed to prepare the gallium Ga 68 gozetotide injection, which according to experts may be used to identify tumour lesions that express the PSMA biomarker and locate where the tumours might have spread.
This helps physicians determine which patients are eligible for Pluvicto's targeted treatment as PSMA is highly expressed in over 80 per cent of patients diagnosed with prostate cancer, making it an essential biomarker for evaluating the extent of disease progression.
According to Novartis, which carried out a study on 831 participants, the cost of the drug will be disclosed soon but the common adverse effects include fatigue, nausea, dry mouth, anaemia, constipation and decreased appetite.
"We believe our innovation can make a meaningful difference to patients," Dr Schaffert added.
