Roman Fabbricatore

3 weeks ago | oncnursingnews.com | Roman Fabbricatore |Russ Conroy

The FDA granted a second complete response letter (CRL) to camrelizumab in combination with rivoceranib as a first line of treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC), according to a news release.1 Initially, the FDA accepted a new drug application (NDA) for the camrelizumab/rivoceranib as a treatment for patients with unresectable HCC in July 2023.2 The FDA sent its initial CRL for camrelizumab/rivoceranib in unresectable liver cancer in May 2024.3...

4 weeks ago | cancernetwork.com | Roman Fabbricatore |Ariana Pelosci

The News The FDA has approved cabozantinib (Cabometyx) as a treatment for adult and pediatric patients 12 years or older with previously treated, unresectable or locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNETs) and well-differentiated extra-pancreatic NETs (epNETs), according to a press release from the FDA.1 Supporting Data The approval for cabozantinib was supported by findings from the phase 3 CABINET trial (NCT03375320), in which investigators...

1 month ago | cancernetwork.com | Roman Fabbricatore |Russ Conroy

The FDA has issued a second complete response letter (CRL) for camrelizumab plus rivoceranib as a frontline treatment for patients with unresectable or metastatic hepatocellular carcinoma (HCC), according to a news release.1According to Korean news sources, the FDA decision was issued March 20, and the CRL did not specify what deficiencies regulators found, according to HLB Group chairman, Jin Yang-gon.

Jan 20, 2025 | cancernetwork.com | Roman Fabbricatore

The approval marks Foundation Medicine’s first companion diagnostic indication to exclusively support pediatric patients with brain tumors.