 | |
| Clinical data | |
|---|---|
| Trade names | Lumisight |
| License data | |
|
Routes of administration | Intravenous |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
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] [4]
Medical uses
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]
History
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]
Society and culture
Pegulicianine is the international nonproprietary name. [5]
References
- ^
a
b
c
d
e
"Archived copy" (PDF).
Archived (PDF) from the original on 18 April 2024. Retrieved 17 April 2024.
{{ cite web}}: CS1 maint: archived copy as title ( link) - ^
a
b
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214511Orig1s000ltr.pdf
Archived 18 April 2024 at the
Wayback Machine
This article incorporates text from this source, which is in the
public domain.
- ^
a
b
c
d
e
f
g
h
i
j
k
"FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy". U.S.
Food and Drug Administration (FDA) (Press release). 17 April 2024.
Archived from the original on 19 April 2024. Retrieved 19 April 2024. This article incorporates text from this source, which is in the
public domain.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
- ^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl: 10665/340684.
External links
- Clinical trial number NCT03686215 for "Investigation of Novel Surgical Imaging for Tumor Excision (INSITE)" at ClinicalTrials.gov
 | This pharmacology-related article is a stub. You can help Wikipedia by expanding it. |
|
| |
| Clinical data | |
|---|---|
| Trade names | Lumisight |
| License data | |
|
Routes of administration | Intravenous |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| UNII | |
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] [4]
Medical uses
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]
History
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]
Society and culture
Pegulicianine is the international nonproprietary name. [5]
References
- ^
a
b
c
d
e
"Archived copy" (PDF).
Archived (PDF) from the original on 18 April 2024. Retrieved 17 April 2024.
{{ cite web}}: CS1 maint: archived copy as title ( link) - ^
a
b
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214511Orig1s000ltr.pdf
Archived 18 April 2024 at the
Wayback Machine This article incorporates text from this source, which is in the
public domain.
- ^
a
b
c
d
e
f
g
h
i
j
k
"FDA approves imaging drug to assist in detection of cancerous tissue following lumpectomy". U.S.
Food and Drug Administration (FDA) (Press release). 17 April 2024.
Archived from the original on 19 April 2024. Retrieved 19 April 2024. This article incorporates text from this source, which is in the
public domain.
- ^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
- ^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl: 10665/340684.
External links
- Clinical trial number NCT03686215 for "Investigation of Novel Surgical Imaging for Tumor Excision (INSITE)" at ClinicalTrials.gov
|
| This pharmacology-related article is a stub. You can help Wikipedia by expanding it. |