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Immunomedics to present CEA-Scan data
Monoclonal antibody imaging agent developer Immunomedics of MorrisPlains, NJ, said this month that the Food and Drug Administrationhas scheduled a date for the company to present data from clinicaltrials for its CEA-Scan colorectal cancer imaging agent.
Monoclonal antibody imaging agent developer Immunomedics of MorrisPlains, NJ, said this month that the Food and Drug Administrationhas scheduled a date for the company to present data from clinicaltrials for its CEA-Scan colorectal cancer imaging agent. The moveis a follow-up to an action last year in which the FDA said CEA-Scan'sproduct license application was not approvable in its form atthe time (SCAN 6/1/94).
The FDA has scheduled the meeting for Oct. 17, at which timethe two parties will discuss the FDA's request for clarificationof the data and analyses Immunomedics provided the agency in responseto the not-approvable letter. The regulatory status of CEA-Scan'sPLA for colorectal cancer imaging is not-yet-approvable, accordingto Immunomedics.
In other Immunomedics news, the company reported progress onseveral other agents it is developing. It said last week thatphase-III clinical trials for its LeukoScan infectious diseaseimaging agent have demonstrated clear diagnostic utility for imagingbone infections. Other trials have supported the use of CEA-Scanin breast cancer imaging.
New Study Assesses Long-Term Outcomes of PSMA PET Use in PCa Recurrence Cases
October 24th 2024For patients with biochemical recurrence of prostate cancer, PSMA PET imaging may facilitate a 12.8 percent lower incidence of prostate cancer mortality in contrast to the combination of CT and bone scan, according to long-term outcome estimates from a new decision-analytic modeling study.
Can Diffusion MRI Predict Patient Response to Neoadjuvant Chemotherapy for Breast Cancer?
October 23rd 2024A model emphasizing time-dependent diffusion MRI was 15 percent more effective than apparent diffusion coefficient (ADC) measurements at predicting pathologic complete response to neoadjuvant chemotherapy for women with breast cancer, according to new research.
