Latest news with #Pluvicto
Yahoo
7 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
7 days ago
- Business
- Yahoo
Novartis reports topline outcomes from trial of Pluvicto for prostate cancer
Novartis has reported topline outcomes from the Phase III PSMAddition trial's pre-specified interim analysis, where Pluvicto (lutetium (177Lu) vipivotide tetraxetan), plus standard of care (SoC), has demonstrated a benefit in treating prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The open-label trial met its primary endpoint, with the combo showing radiographic progression-free survival (rPFS) benefits with a positive trend in overall survival (OS) in this subject population. The SoC in the PSMAddition trial includes a combo of androgen receptor pathway inhibitor (ARPI) therapy and androgen deprivation therapy (ADT). This is the third positive read-out for this intravenous radioligand therapy (RLT), Pluvicto, in a Phase III trial, after the VISION and PSMAfore trials. According to the company, findings from PSMAddition for mHSPC treatment show potential for treatment in an earlier setting with the RLT. PSMAddition is a prospective, randomised trial that assesses the safety and efficacy of Pluvicto plus SoC versus SoC alone. Subjects in the SoC arm are permitted to cross over to receive the RLT upon radiographic progression, as confirmed by a blinded independent review committee (BIRC). Novartis noted that detailed data from the PSMAddition trial will be presented at a future medical meeting and submitted for regulatory review later this year. The US Food and Drug Administration (FDA) recently approved the RLT for earlier use in mCRPC, based on outcomes from the PSMAfore trial. Novartis Development president and chief medical officer Shreeram Aradhye said: 'The progression from metastatic hormone-sensitive prostate cancer to castration-resistant disease remains a formidable challenge that can profoundly impact the survival of patients. 'Following the recent FDA approval based on the PSMAfore trial in metastatic castration-resistant prostate cancer, these data suggest using it in an earlier disease setting could advance care and address a significant unmet need for hormone-sensitive prostate cancer patients." This March, Novartis reported positive efficacy and safety outcomes from the Phase III clinical programme for OAV101 IT (onasemnogene abeparvovec), an investigational intrathecal therapy intended for spinal muscular atrophy (SMA) in subjects aged two to less than 18 years. "Novartis reports topline outcomes from trial of Pluvicto for prostate cancer " was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
02-06-2025
- Business
- Yahoo
Novartis' Pluvicto shown to slow prostate cancer in earlier setting
FRANKFURT (Reuters) -Novartis said on Monday that its targeted radiotherapy Pluvicto was shown to slow progression of a certain type of prostate cancer, raising the prospect of treatment in an earlier disease stage for a drug technology that the drugmaker has pioneered. The Swiss drugmaker reported a late-stage trial showed a "clinically meaningful benefit" in progression-free survival with a positive trend in overall survival in patients with metastatic prostate cancer that still responds to standard hormone therapy. Almost all of those patients ultimately progress to a form of cancer that no longer responds to hormone therapy, a setting where Pluvicto is already approved, the company added. "These data suggest using (Pluvicto) in an earlier disease setting," Novartis said, adding that this could address a significant unmet need. Novartis only provided a brief summary of trial results and said details would be presented at a medical conference and that it would likely request regulatory approval for wider use in the second half of the year. Pluvicto is part of a class of drugs that combines cell-killing radioactive particles with molecules that attach themselves to tumours, where Novartis has a leading position. The drug saw first-quarter revenue gain 20% to $371 million. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Reuters
02-06-2025
- Business
- Reuters
Novartis' Pluvicto shown to slow prostate cancer in earlier setting
FRANKFURT, June 2 (Reuters) - Novartis (NOVN.S), opens new tab said on Monday that its targeted radiotherapy Pluvicto was shown to slow progression of a certain type of prostate cancer, raising the prospect of treatment in an earlier disease stage for a drug technology that the drugmaker has pioneered. The Swiss drugmaker reported a late-stage trial showed a "clinically meaningful benefit" in progression-free survival with a positive trend in overall survival in patients with metastatic prostate cancer that still responds to standard hormone therapy. Almost all of those patients ultimately progress to a form of cancer that no longer responds to hormone therapy, a setting where Pluvicto is already approved, the company added. "These data suggest using (Pluvicto) in an earlier disease setting," Novartis said, adding that this could address a significant unmet need. Novartis only provided a brief summary of trial results and said details would be presented at a medical conference and that it would likely request regulatory approval for wider use in the second half of the year. Pluvicto is part of a class of drugs that combines cell-killing radioactive particles with molecules that attach themselves to tumours, where Novartis has a leading position. The drug saw first-quarter revenue gain 20% to $371 million.
Yahoo
02-06-2025
- Business
- Yahoo
Novartis' Pluvicto shown to slow prostate cancer in earlier setting
FRANKFURT (Reuters) -Novartis said on Monday that its targeted radiotherapy Pluvicto was shown to slow progression of a certain type of prostate cancer, raising the prospect of treatment in an earlier disease stage for a drug technology that the drugmaker has pioneered. The Swiss drugmaker reported a late-stage trial showed a "clinically meaningful benefit" in progression-free survival with a positive trend in overall survival in patients with metastatic prostate cancer that still responds to standard hormone therapy. Almost all of those patients ultimately progress to a form of cancer that no longer responds to hormone therapy, a setting where Pluvicto is already approved, the company added. "These data suggest using (Pluvicto) in an earlier disease setting," Novartis said, adding that this could address a significant unmet need. Novartis only provided a brief summary of trial results and said details would be presented at a medical conference and that it would likely request regulatory approval for wider use in the second half of the year. Pluvicto is part of a class of drugs that combines cell-killing radioactive particles with molecules that attach themselves to tumours, where Novartis has a leading position. The drug saw first-quarter revenue gain 20% to $371 million. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
