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[SITUATION] · [ACTIVE] · [HEALTH]
2 clusters · 3 sources · 14 days · First seen · Last updated
Johnson & Johnson oncology clinical developments
Overview
Johnson & Johnson reported positive results from several oncology clinical trials. Data presented at the European Society for Medical Oncology Congress indicated that the drug Erleada, when used in combination with androgen deprivation therapy, showed a 62% reduction in the risk of recurrence or death for high-risk prostate cancer patients. Additionally, early-stage trials for the investigational drug JNJ-6143 demonstrated anti-tumor activity in patients with advanced prostate cancer, while the RYBREVANT FASPRO regimen achieved a 77% overall response rate in patients with recurrent or metastatic head and neck squamous cell carcinoma.
Following these developments, the US Food and Drug Administration granted accelerated approval to Rybrevant Faspro for treating adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed after platinum-based chemotherapy and checkpoint inhibitor treatment. This marks the first indication for the EGFR-MET bispecific antibody beyond non-small cell lung cancer. Clinical data from the Phase Ib/II OrigAMI-4 trial showed a 42% confirmed overall response rate in the approved patient group.
Entities
Johnson & Johnson · Novo Nordisk · OrigAMI-4 trial · United States · Rybrevant Faspro
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 3 SOURCES] The FDA granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for recurrent or metastatic head and neck squamous cell carcinoma. www.pharmexec.com · grafa.com · cryptocompass.com
- [● 3 SOURCES] Rybrevant Faspro is an EGFR-MET bispecific antibody. www.pharmexec.com · grafa.com · cryptocompass.com
- [● 3 SOURCES] The Phase Ib/II OrigAMI-4 trial showed a 42% response rate among 102 patients. www.pharmexec.com · grafa.com · cryptocompass.com
- [● 2 SOURCES] The approval excludes patients with HPV-associated oropharyngeal squamous cell carcinoma. grafa.com · cryptocompass.com
- [● 2 SOURCES] Rybrevant Faspro is administered via subcutaneous injection. grafa.com · cryptocompass.com
- [○ 1 SOURCE] Serious adverse reactions occurred in 39% of patients in the OrigAMI-4 trial. grafa.com
- [○ 1 SOURCE] Fatal adverse reactions occurred in 6% of patients in the OrigAMI-4 trial. grafa.com
- [○ 1 SOURCE] Johnson & Johnson stock rose 0.35% to $273.27 following the announcement. cryptocompass.com
Timeline
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[HEALTH] 3 sourcesJohnson & Johnson receives FDA accelerated approval for Rybrevant Faspro
The FDA granted accelerated approval to Johnson & Johnson’s Rybrevant Faspro for treating certain recurrent or metastatic head and neck squamous cell carcinomas.
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[HEALTH] 7 sourcesJohnson & Johnson reports positive clinical trial results for cancer treatments
Johnson & Johnson announced positive clinical data for several cancer therapies, including Erleada for prostate cancer and the RYBREVANT FASPRO regimen for head and neck squamous cell carcinoma.
Sources
cryptocompass.com · pharmexec.com · revistaprevenir.com.br