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