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Targovax’s ONCOS-102 receives Fast-Track designation from US FDA

Author : Pankaj Singh | Published Date : 2021-02-16 
  • The US FDA grants ONCOS-102 Fast-Track designation for lung cancer treatment.
  • Fast-Track designation increases potential of speeding up development and reviewal process with the US FDA.

Norway-based clinical-stage immune-oncology company producing immune activators to target hard-to-treat solid tumors, Targovax ASA, recently announced that its premier candidate ONCVOS-102 for treating malignant pleural mesothelioma (MPM) received Fast Track designation from the United States Food and Drugs Administration.

Trusted sources cited that the US regulator granted Fast-Track designation to ONCOS-102 after reviewing pre-clinical and clinical efficacy linked to the broad immune activation witnessed to date.

It is to be noted that obtaining this designation by the US FDA is a recognition of the strength of the ONCOS-102 data package as the designation is bestowed to therapies that show promise in addressing the unmet needs in serious medical conditions.

This allows for more frequent interactions with FDA to accelerate clinical development as well as the review process. Products with this designation have better chances of a Priority Review for future BLA (Biologics License Application) and may be permitted to submit parts of the application ahead to shorten the review cycle.

Vice President Regulatory Affairs, Dr. Ingunn Munch Lindvig, expressed that gaining the Fast-Track designation is a major milestone for the ONCOS-102 program as it backs up the strong potential of the therapy as a future treatment option for solid tumors with high unmet needs.

For the record, ONCOS-102 already has Orphan Drug Designation (ODD) from the European MEA and US FDA in the mesothelioma indication, enabling ONCOS-102 market exclusivity for 10 and 7 years in the EU and USA, respectively, starting from the date of BLA grant, sources confirmed.

In another major development, last week, Targovax ASA and Papyrus Therapeutics joined hands to develop an ONCOS virus concept with the functionality of receptor tyrosine kinase (RTK) inhibitor, cited reliable sources.

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About Author

Pankaj Singh

Pankaj Singh

Endowed with a post graduate degree in management and finance, Pankaj Singh has been a part of the online content domain for quite a while. Having worked previously as a U.K. insurance underwriter for two years, he now writes articles for fractovia.org and other online portals. He can be contacted at- [email protected] | https://twitter.com/PankajSingh2605

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