Fast track is given to accelerate the development and review of investigational therapies aimed at treating serious or life-threatening conditions, and addressing an unmet medical need. With this designation, Lumicell will now have the chance to engage in early and frequent interactions with the FDA to discuss the next steps in the regulatory review process for its imaging system.
Additionally, the technology company is planning to take advantage of the possibility of submitting a rolling review — another benefit that comes with fast track — to submit portions of a new drug application (NDA), a regulatory request for approval, for FDA review as soon as possible.
With a rolling application, companies have the opportunity to submit NDA modules as soon as they are completed, rather than gathering all required clinical information before submitting their full and final NDA.
According to Lumicell, this new fast track designation represents another important milestone in its cancer detection system’s path to approval.
“The FDA’s decision to grant Fast Track Designation is an important step in bringing the Lumicell Imaging System closer to FDA approval and providing surgeons with this innovative technology to detect and remove cancerous tissue more confidently and efficiently than ever before,” Kevin Hershberger, president and CEO at Lumicell, said in a press release.
The company’s LUM Imaging System was designed by engineers and scientists in collaboration with breast cancer specialists, and is specifically intended to allow surgeons to identify and remove residual cancerous tissue in real-time during surgery, lowering the risks of cancer recurrence and the need for additional surgical procedures.
The system comprises three different components. One is an investigational fluorescent imaging agent, called LUM015, that is specifically designed to emit a fluorescent signal when it approaches cancer cells at the tumor margins, while another is a lightweight, hand-held imaging device that can be placed inside the surgical wound cavity to look for cancerous residual tissue at the tumor margins. The third component is a proprietary software that is able to produce real-time images, provided to surgeons, indicating the location of the remaining cancer tissue.
“It’s a fresh approach to in-vivo [in-the-body] cancer surgeries. Instead of focusing on what was in the lumpectomy specimen, we prioritize what’s left behind in the cavity,” Wapnir added.
Three clinical trials already have been completed: a Phase 1 (NCT01626066) and two Phase 2 studies (NCT02438358; NCT03321929) that assessed the safety and feasibility of Lumicell’s cancer imaging system in patients with breast cancer. Data from these trials demonstrated that LUM015 had a favorable safety and pharmacological profile, and showed the LUM Imaging System enabled surgeons to rapidly identify small portions of residual tumor during cancer removal surgery.
Another Phase 2 trial (NCT04440982) is currently underway to evaluate LUM Imaging System’s capacity to detect residual cancer in patients with breast cancer undergoing breast-conserving surgery as neoadjuvant therapy. In neoadjuvant therapy, treatment is given as a first step to shrink a tumor before the main therapy, which usually is surgery. Recruitment for that trial is underway at several sites across the U.S. More information be found here.
In addition, a pivotal Phase 3 trial (NCT03686215) is ongoing to assess the safety and efficacy of the LUM Imaging System in women with breast cancer. Recruitment is taking place at several sites across the U.S, with the trial expected to enroll approximately 170 women. More information about trial contacts and recruiting sites can be found here. That trial is expected to conclude by March 2021.
“We are very excited with the progress as we continue enrollment in our Breast Cancer Pivotal Trial which we expect will further build on the strong clinical data Lumicell demonstrated in our multi-center feasibility clinical study,” Hershberger said.
Lumicell’s LUM Imaging System had previously received the FDA’s breakthrough device designation for breast cancer and other types of solid tumors. Like fast track, that designation is given to medical devices or combination products that are shown to be more effective than currently available treatments at treating life-threatening diseases. It also is designed to accelerate the development and review process.
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