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| Trade names | Lumisight |
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| Routes of administration | Intravenous |
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Pegulicianine, sold under the brand name Lumisight, is an optical imaging agent. [1] It is given via intravenous injection. [1]
Pegulicianine was approved for medical use in the United States in April 2024. [1] [2] [3]
Pegulicianine is indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. [1] [2] [3]
The efficacy and safety of pegulicianine were evaluated in a multicenter, intra-participant controlled clinical trial (NCT03686215) of participants with breast cancer undergoing lumpectomy surgery. [3] A total of 357 participants underwent image-guided surgery with the Lumicell DVS following standard of care lumpectomy. [3] When positive pegulicianine signal was detected, the tissue was resected with a cavity shave procedure. [3] The study assessed the proportion of participants receiving pegulicianine who had residual cancer detected and removed after the standard of care lumpectomy. [3] A total of 27 of 357 participants (7.6%) had cancer in at least one pegulicianine-guided shave. [3] The study also assessed the image-level sensitivity (ability to designate an imaged region with disease as positive) and specificity (ability to designate an imaged region without disease as negative) for detection of cancer in the lumpectomy cavity. [3] Sensitivity was 49.1% and specificity was 86.5%. [3] Forty-three percent (43%) of participants had at least one false positive image and 8% of participants had at least one false negative image. [3]
The FDA granted the application for pegulicianine fast track and priority review designations. [3]
Pegulicianine is the international nonproprietary name. [4]
Mammography is the process of using low-energy X-rays to examine the human breast for diagnosis and screening. The goal of mammography is the early detection of breast cancer, typically through detection of characteristic masses or microcalcifications.
Lumpectomy is a surgical removal of a discrete portion or "lump" of breast tissue, usually in the treatment of a malignant tumor or breast cancer. It is considered a viable breast conservation therapy, as the amount of tissue removed is limited compared to a full-breast mastectomy, and thus may have physical and emotional advantages over more disfiguring treatment. Sometimes a lumpectomy may be used to either confirm or rule out that cancer has actually been detected. A lumpectomy is usually recommended to patients whose cancer has been detected early and who do not have enlarged tumors. Although a lumpectomy is used to allow for most of the breast to remain intact, the procedure may result in adverse affects that can include sensitivity and result in scar tissue, pain, and possible disfiguration of the breast if the lump taken out is significant. According to National Comprehensive Cancer Network guidelines, lumpectomy may be performed for ductal carcinoma in situ (DCIS), invasive ductal carcinoma, or other conditions.
Ductal carcinoma in situ (DCIS), also known as intraductal carcinoma, is a pre-cancerous or non-invasive cancerous lesion of the breast. DCIS is classified as Stage 0. It rarely produces symptoms or a breast lump that can be felt, typically being detected through screening mammography. It has been diagnosed in a significant percentage of men.
Ocrelizumab, sold under the brand name Ocrevus, is a medication used for the treatment of multiple sclerosis (MS). It is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and is an immunosuppressive drug. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds.
Breast cancer management takes different approaches depending on physical and biological characteristics of the disease, as well as the age, over-all health and personal preferences of the patient. Treatment types can be classified into local therapy and systemic treatment. Local therapy is most efficacious in early stage breast cancer, while systemic therapy is generally justified in advanced and metastatic disease, or in diseases with specific phenotypes.
Breast cancer screening is the medical screening of asymptomatic, apparently healthy women for breast cancer in an attempt to achieve an earlier diagnosis. The assumption is that early detection will improve outcomes. A number of screening tests have been employed, including clinical and self breast exams, mammography, genetic screening, ultrasound, and magnetic resonance imaging.
Margetuximab, sold under the brand name Margenza, is a chimeric IgG monoclonal antibody medication against HER2 used for the treatment of cancer.
Technetium (99mTc) tilmanocept, sold under the brand name Lymphoseek, is a radiopharmaceutical diagnostic imaging agent used to locate lymph nodes which may be draining from tumors, and assist doctors in locating lymph nodes for removal during surgery.
Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, cervical cancer, and certain types of breast cancer. It is administered by slow intravenous injection.
Sacituzumab govitecan, sold under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer.
In medicine, breast imaging is a sub-speciality of diagnostic radiology that involves imaging of the breasts for screening or diagnostic purposes. There are various methods of breast imaging using a variety of technologies as described in detail below. Traditional screening and diagnostic mammography uses x-ray technology and has been the mainstay of breast imaging for many decades. Breast tomosynthesis is a relatively new digital x-ray mammography technique that produces multiple image slices of the breast similar to, but distinct from, computed tomography (CT). Xeromammography and galactography are somewhat outdated technologies that also use x-ray technology and are now used infrequently in the detection of breast cancer. Breast ultrasound is another technology employed in diagnosis and screening that can help differentiate between fluid filled and solid lesions, an important factor to determine if a lesion may be cancerous. Breast MRI is a technology typically reserved for high-risk patients and patients recently diagnosed with breast cancer. Lastly, scintimammography is used in a subgroup of patients who have abnormal mammograms or whose screening is not reliable on the basis of using traditional mammography or ultrasound.
Alectinib (INN,), sold under the brand name Alecensa, is an anticancer medication that is used to treat non-small-cell lung cancer (NSCLC). It blocks the activity of anaplastic lymphoma kinase (ALK). It is taken by mouth. It was developed by Chugai Pharmaceutical Co. Japan, which is part of the Hoffmann-La Roche group.
Mirvetuximab soravtansine, sold under the brand name Elahere, is a medication used as a treatment for epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Mirvetuximab soravtansine is a folate receptor alpha directed antibody and microtubule inhibitor conjugate.
Tucatinib, sold under the brand name Tukysa, is an anticancer medication used for the treatment of HER2-positive breast cancer. It is a small molecule inhibitor of HER2. It was developed by Array BioPharma and licensed to Cascadian Therapeutics.
Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody used as an anti-cancer medication for the treatment of endometrial cancer. Dostarlimab is a programmed death receptor-1 (PD-1)–blocking monoclonal antibody.
Trastuzumab deruxtecan, sold under the brand name Enhertu, is an antibody-drug conjugate consisting of the humanized monoclonal antibody trastuzumab (Herceptin) covalently linked to the topoisomerase I inhibitor deruxtecan. It is licensed for the treatment of breast cancer or gastric or gastroesophageal adenocarcinoma. Trastuzumab binds to and blocks signaling through epidermal growth factor receptor 2 (HER2/neu) on cancers that rely on it for growth. Additionally, once bound to HER2 receptors, the antibody is internalized by the cell, carrying the bound deruxtecan along with it, where it interferes with the cell's ability to make DNA structural changes and replicate its DNA during cell division, leading to DNA damage when the cell attempts to replicate itself, destroying the cell.
Flortaucipir (18F), sold under the brand name Tauvid, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging to image the brain.
Piflufolastat F-18, sold under the brand name Pylarify among others, is a radioactive diagnostic agent used for positron emission tomography (PET) imaging. It is given by intravenous injection.
Gallium (68Ga) gozetotide or Gallium (68Ga) PSMA-11 sold under the brand name Illuccix among others, is a radiopharmaceutical made of 68Ga conjugated to prostate-specific membrane antigen (PSMA) targeting ligand, Glu-Urea-Lys(Ahx)-HBED-CC, used for imaging prostate cancer by positron emission tomography (PET). The PSMA targeting ligand specifically directs the radiolabeled imaging agent towards the prostate cancerous lesions in men.
Pafolacianine, sold under the brand name Cytalux, is an optical imaging agent used in fluorescence-guided surgery. Pafolacianine is a fluorescent medication that binds to folate receptor (FR)-expressing cells.
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