The Food and Drug Administration has asked radiopharmaceutical developer Palatin Technologies for more data regarding the firm's biologics license application (BLA) for its LeuTech agent. The letter says the FDA has completed its review of the Princeton, NJ-based vendor’s clinical efficacy and safety data, but needs additional manufacturing and process validation data prior to approval, according to Palatin.
Although the manufacturing issues will affect the timing of LeuTech’s launch, Palatin plans to file an amendment as expeditiously as possible to secure final approval for the agent, according to president and CEO Dr. Carl Spana. LeuTech is a monoclonal antibody for diagnosing appendicitis in patients with equivocal symptoms, according to Palatin.
By AuntMinnie.com staff writersSeptember 28, 2000
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Palatin closes financing, September 19, 2000
Palatin shuffles management, June 14, 2000
Palatin reports lower Q1 loss, May 10, 2000
Merger between contrast firms MBI and Palatin collapses, March 14, 2000
FDA to begin reviewing Palatin infection imaging agent, February 2, 2000
Copyright © 2000 AuntMinnie.com
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
