Ipsen’s Onivyde regimen granted FDA approval to treat pancreatic cancer

2024-02-15

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Ipsen’s Onivyde regimen granted FDA approval to treat pancreatic cancer

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来源: PMLiVE

Ipsen’s Onivyde (irinotecan liposome injection) regimen has been approved by the US Food and Drug Administration (FDA) to treat pancreatic cancer.

Onivyde plus oxaliplatin, fluorouracil and leucovorin (Nalirifox) can now be used as a first-line treatment for adults with metastatic pancreatic adenocarcinoma (mPDAC).

PDAC is the most common type of pancreatic cancer, with approximately 60,000 people diagnosed with the disease in the US every year.

Since there are no specific symptoms in the early stages, PDAC is often detected late, after the disease has spread to other parts of the body.

The FDA’s decision on the Onivyde regimen was supported by positive results from the late-stage NAPOLI 3 trial, in which Nalirifox was associated with a statistically significant improvement in median overall survival of 11.1 months compared to 9.2 months for patients treated with the standard regimen of Bristol Myers Squibb’s Abraxane (nab-paclitaxel) plus gemcitabine.

Nalirifox also demonstrated a statistically significant improvement in median progression-free survival of 7.4 months versus 5.6 months for the standard care group.

“The results from the phase 3 NAPOLI 3 trial represent the first positive data for an investigational regimen in first-line metastatic pancreatic adenocarcinoma versus the currently approved nab-paclitaxel and gemcitabine regimen,” explained Christelle Huguet, executive vice president and head of research and development at Ipsen.

“With [the] approval, this Onivyde (Nalirifox) regimen can now offer a potential new standard of care treatment option with proven survival benefits for people living with mPDAC in the US,” she added.

Onivyde is already approved in major markets, including the US, in combination with fluorouracil and leucovorin to treat adults with mPDAC who are experiencing disease progression following gemcitabine-based therapy.

Ipsen has exclusive commercialisation rights for the current and potential future indications for Onivyde Onivyde in the US, while Servier is responsible for the commercialisation of Onivyde Onivyde outside of the US and Taiwan, where PharmaEngine holds the commercialisation rights.

Commenting on the latest Onivyde regimen approval, Dr Zev Wainberg, professor of medicine and co-director of the UCLA GI oncology programme, said: “Given the reality of this aggressive form of cancer and the complexity of the disease, every advance in the treatment landscape represents a meaningful improvement in patient outcomes.”

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