Iovance Bio updates cervical cancer program data post FDA meeting
Category: #health  By Mateen Dalal  Date: 2019-07-04
  • share
  • Twitter
  • Facebook
  • LinkedIn

Iovance Bio updates cervical cancer program data post FDA meeting

The innovaTIL-04 study is anticipated to register a total of 75 to 100 patients with the aim to support a BLA submission

Reports confirm that Iovance Biotherapeutics, Inc., a biotech company, has recently provided update regarding the regulatory path for LN-145 in advanced cervical cancer program, following the End of Phase 2 meeting conducted with the U.S. Food and Drug Administration.

Apparently, the FDA has acknowledged that the current innovaTIL-04 study of LN-145, a TIL treatment, might be enough for supporting enrolment in the treatment of advanced cervical cancer patients. The study is being registered with a potential definition of objective response rate stated by a Blinded Independent Review Committee as the primary endpoint.

Sources mentioned that in accordance with the recommendation of FDA, the novel version of the protocol will further describe the patient population. In the Biologics License Application, Iovance formally plans to include patients who have advanced following initial systemic therapy for metastatic or recurrent disease, which accounts for almost overall more advanced patients registered till date.

Along with this, the company had announced that the innovaTIL-04 study is anticipated to register a total of 75 to 100 patients with the aim to support a BLA submission.

According to Chief Executive Officer and President of Iovance Biotherapeutics, Maria Fardis, Ph.D., the agreement with FDA is to consider acceptability of the existing trial in patients suffering with cervical cancer considerably accelerates the way to BLA submission for LN-145. The capability to use the existing study, as well as the Breakthrough Therapy label recently granted to LN-145, enables the company to plan a route to submitting BLA in the second half of 2020.

For the uninitiated, Iovance Biotherapeutics develops innovate cancer immunotherapies that are based on tumor-infiltrating lymphocyte technology. It aims to market autologous cell therapy portfolio that strengthens the immune response of the body itself to attack blood cancers or eliminate solid tumors. The company is presently performing the key study innovaTIL-01 in patients with metastatic melanoma.

Source Credit: http://ir.iovance.com/phoenix.zhtml?c=254507&p=irol-newsArticle&ID=2402832

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

Microsoft investigates Teams and Outlook outage that left users disrupted
Microsoft investigates Teams and Outlook outage that left users disrupted
By Mateen Dalal

Microsoft, the U.S.-based technology frontrunner, reportedly investigating an outage that prevented thousands of customers from accessing services like Teams and Outlook. Apparently, the tech giant did not disclose the number of users that were im...

DeHaat secures $60 million in funding, tops $700 million valuation
DeHaat secures $60 million in funding, tops $700 million valuation
By Mateen Dalal

Indian agritech firm DeHaat has reportedly raised $60 million in a new funding round as it looks forward to strengthening its footprint in the country and touching break-even profitability in two years. For the unversed, the startup provides a range ...

Sensorium registers new branch in UAE to expand global presence
Sensorium registers new branch in UAE to expand global presence
By Mateen Dalal

Sensorium, developer of the Sensorium Galaxy metaverse, has registered its new branch in the United Arab Emirates (UAE) as Dubai gradually becomes a global hub for metaverse companies. The new entity, slated to be officially inaugurated in the com...