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Novartis' (NVS) Pluvicto Gets FDA Nod for Advanced Prostate Cancer
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Novartis AG (NVS - Free Report) announced that the FDA has approved its targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive or PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). These patients with progressing mCRPC were pre-treated with other anti-cancer therapies like androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
Following the FDA nod, Pluvicto became the first targeted radioligand therapy to be approved for treating eligible patients with mCRPC. The drug is expected to be launched in the upcoming weeks in the United States.
The FDA nod for Pluvicto was based on data from the phase III VISION study. Outcomes from the same showed that treatment with Pluvicto plus the standard of care or SOC in pre-treated PSMA-positive mCRPC patients led to a statistically significant reduction in risk of death. Treatment with Pluvicto plus SOC improved the overall survival as well as led to a significant reduction in the risk of radiographic disease progression or death versus SOC alone – the alternate primary endpoints.
The FDA also approved NVS’ complementary diagnostic imaging agent Locametz, which can be used to identify PSMA-positive lesions in mCRPC patients through a positron emission tomography or PET scan after radiolabeling. The product is also expected to be available in the United States in the upcoming weeks.
Novartis also filed regulatory applications to the European Medicines Agency and other health authorities across the world, seeking approvals for both Pluvicto and Locametz.
Shares of Novartis have lost 2.2% so far this year against the industry’s increase of 1.9%.
Image Source: Zacks Investment Research
The radioligand therapy combines a targeting compound, which binds to markers expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication.
Novartis is currently evaluating Pluvicto in two other pivotal phase III studies targeting earlier lines of treatment for metastatic prostate cancer.
Per management, mCRPC patients who progress on multiple lines of therapy have limited treatment options available. Hence, the approval for precision medicine Pluvicto can significantly improve the survival rates of the given patient population, thereby serving an area of high unmet medical need.
The approval for Pluvicto is likely to strengthen and diversify Novartis’ oncology portfolio.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank of #4 (Sell).
Better-ranked stocks in the healthcare sector include Innoviva, Inc. (INVA - Free Report) , Collegium Pharmaceutical, Inc. (COLL - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have been revised 20.5% upward for 2022 and 27.9% for 2023 over the past 60 days. The INVA stock has rallied 12.3% year to date.
Earnings of Innoviva surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% for 2023 over the past 60 days. The COLL stock has gained 2.2% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 8.7% upward for 2022 and 8.4% for 2023 over the past 60 days. The VRTX stock has increased 13% year to date.
Earnings of Vertex surpassed estimates in each of the trailing four quarters.
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Novartis' (NVS) Pluvicto Gets FDA Nod for Advanced Prostate Cancer
Novartis AG (NVS - Free Report) announced that the FDA has approved its targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive or PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). These patients with progressing mCRPC were pre-treated with other anti-cancer therapies like androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.
Following the FDA nod, Pluvicto became the first targeted radioligand therapy to be approved for treating eligible patients with mCRPC. The drug is expected to be launched in the upcoming weeks in the United States.
The FDA nod for Pluvicto was based on data from the phase III VISION study. Outcomes from the same showed that treatment with Pluvicto plus the standard of care or SOC in pre-treated PSMA-positive mCRPC patients led to a statistically significant reduction in risk of death. Treatment with Pluvicto plus SOC improved the overall survival as well as led to a significant reduction in the risk of radiographic disease progression or death versus SOC alone – the alternate primary endpoints.
The FDA also approved NVS’ complementary diagnostic imaging agent Locametz, which can be used to identify PSMA-positive lesions in mCRPC patients through a positron emission tomography or PET scan after radiolabeling. The product is also expected to be available in the United States in the upcoming weeks.
Novartis also filed regulatory applications to the European Medicines Agency and other health authorities across the world, seeking approvals for both Pluvicto and Locametz.
Shares of Novartis have lost 2.2% so far this year against the industry’s increase of 1.9%.
Image Source: Zacks Investment Research
The radioligand therapy combines a targeting compound, which binds to markers expressed by tumors and a radioactive isotope, causing DNA damage that inhibits tumor growth and replication.
Novartis is currently evaluating Pluvicto in two other pivotal phase III studies targeting earlier lines of treatment for metastatic prostate cancer.
Per management, mCRPC patients who progress on multiple lines of therapy have limited treatment options available. Hence, the approval for precision medicine Pluvicto can significantly improve the survival rates of the given patient population, thereby serving an area of high unmet medical need.
The approval for Pluvicto is likely to strengthen and diversify Novartis’ oncology portfolio.
Zacks Rank & Stocks to Consider
Novartis currently carries a Zacks Rank of #4 (Sell).
Better-ranked stocks in the healthcare sector include Innoviva, Inc. (INVA - Free Report) , Collegium Pharmaceutical, Inc. (COLL - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) . While Innoviva and Collegium Pharmaceutical sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have been revised 20.5% upward for 2022 and 27.9% for 2023 over the past 60 days. The INVA stock has rallied 12.3% year to date.
Earnings of Innoviva surpassed estimates in each of the trailing four quarters.
Collegium Pharmaceutical’s earnings estimates have been revised 51.9% upward for 2022 and 66.2% for 2023 over the past 60 days. The COLL stock has gained 2.2% year to date.
Earnings of Collegium Pharmaceutical surpassed estimates in one of the trailing four quarters and missed the same on the other three occasions.
Vertex’s earnings estimates have been revised 8.7% upward for 2022 and 8.4% for 2023 over the past 60 days. The VRTX stock has increased 13% year to date.
Earnings of Vertex surpassed estimates in each of the trailing four quarters.