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FDA approves Ipsen’s Onivyde for pancreatic adenocarcinoma
临床3期临床结果上市批准快速通道
Ipsen’s Onivyde regimen is indicated as a first-line treatment for metastatic pancreatic adenocarcinoma. Credit: MattL_Images / Shutterstock.com.
The US FOnivyde Drug Administration approved Ipsen‘s supplemental nmetastatic pancreatic adenocarcinoma(irinotecan liposome injection) combination regimen (NALIRIFOX) as a first-line treatment for metastatic pancreatic adenocarcinoma (mPDAC) in adults.
The treFood and Drug Administrationwith oxaliplatin, fluorouracil and leucovorin.Onivydeirinotecanmetastatic pancreatic adenocarcinoma (mPDAC)
It is the second FDA approval for an Onioxaliplatinn fluorouracilpandileucovorinnt options for patients.
The latest approval is based on Onivydes fromfluorouracilII NAleucovorinnical trial.gemcitabine
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The open-label, randomised trial enrolled 770 individuals across 187 sites in 18 countries.
The triFDAmet its primary and secondary endpoints, showing improvements in survival rates for subjects treated with the Onivyde regimen compared to those receiving nab-paclitaxel and gemcitabine.
Patients treated with the Onivyde regimen, NALIRIFOX, experienced a median overall survival of 11.1 months, notably longer than the 9.2 months observed in patients treated with nab-paclitaxel and gemcitabine.
The Onivyde combination also led to a median progression-free survival of 7.4 months, compared to 5.6 months under the alternative treatment.
The objective response rate for the NALIRIFOX regimen was 41.8%, against the 36.2% rate for those receiving nab-paclitaxOnivydegemcitabine.nab-paclitaxelgemcitabine
Despite the potential for Onivyde adverse events such as fatal neutropenic fever and severe diarrhoea, the safety profile of the Onivyde regimen was deemed manageable.nab-paclitaxelgemcitabine
IpseOnivyderch and Development EVP and head Christelle Huguet stated: “With today’s approval, this Onivyde (NALIRIFOX) regimen can now offer a potential new standard-of-care treatment option with proven survival benefits for people living with metastatic pancreatic adenocarcinoma in the US.”
Ipsen holds sole rights to market Onivyde in the US for existing and future indications while Servier will cnab-paclitaxelhe thgemcitabinede the US and Taiwan.
In August 2023, Ipsen received FDA approval for Sohonos (palovaneutropenic feverto treat fibdiarrhoeaia ossificans progressiva.Onivyde
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