Small Cell Lung Cancer – Fast Track Designation to Onivyde


The FDA granted fast track designation to Onivyde injection for the treatment of patients with Small Cell Lung Cancer, SCLC, who progressed following a first-line platinum-based regimen.

The fast track designation of Onivyde as a potential treatment for people living with this aggressive cancer, is a contribution to the treatment landscape in oncology. These are great news in the fight against this aggressive and often late-stage diagnosed form of lung cancer.

3 facts about Small Cell Lung Cancer, SCLC

  1. This cancer constitutes for approx. 15% of lung cancers and is considered to be particularly aggressive
  2. Its source is in cells from the central region of the lung and connection was found with smoking habits
  3. This cancer spreads rapidly

This why there is an urgent need for new therapeutic options especially as the standard of care options are simply disappointing in this type of cancer.

The agent is still evaluated in an ongoing phase 3 trial (NCT03088813), designed to evaluate the efficacy and safety of Onivyde as a monotherapy for patients with SCLC who have progressed on or after a first-line platinum-based regimen.

About Onivyde, also called Irinotecan Liposome

Topoisomerase 1 enzyme cuts one of the two strands of double-stranded DNA

ONIVYDE is a topoisomerase inhibitor. It works by blocking topoisomerase 1 which results in DNA damage and cell death

Common side effects of Onivyde

Diarrhea, vomiting, bone marrow suppression, hair loss, shortness of breath and fever

Other severe side effects include blood clots, colon inflammation and allergic reactions

Those with two copies of the UGT1A1*28 gene variant are at higher risk for side effects

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For further reading>>

About the RESILIENT trial (NCT03088813)>>

About Small Cell Lung Cancer, SCLC>>

Small Cell Lung Cancer and Onivyde
Small Cell Lung Cancer and Onivyde

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