FDA Grants Fast Track Designation to Onivyde in Small Cell Lung Cancer

The FDA has granted a Fast Track designation to the irinotecan liposome injection (Onivyde) as a potential treatment option for patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen, Ipsen announced, in a press release.

Progression on frontline therapy is indicative of an unmet medical need in the field. With a Fast Tack designation, Ipsen may have more frequent encounters with the FDA to aid in the development of the irinotecan liposome injection. Having a Fast Tack designation also makes the agent eligible for accelerated approval and priority review if the study of the agent meets its criteria.

“The Fast Track designation of Onivyde as a potential treatment for people living with small cell lung cancer is an extension of Ipsen’s focus and contribution to the treatment landscape in oncology,” said Howard Mayer, MD, executive vice president, and head of Research and Development at Ipsen, in a statement. “With this aggressive and often late-stage diagnosed form of lung cancer, we are proud to be one step closer to making another treatment option available to patients.”

The irinotecan liposome injection is currently under evaluation in the phase 3 RESILENT clinical trial (NCT03088813). The agent is be evaluated against topotecan in approximately 480 patients. The goal of the study is to assess the efficacy and safety of the irinotecan liposome injection a monotherapy for in patients with SCLC who have progressed on or after a first-line platinum-based regimen. The primary end point of RESILIENT is overall survival, and the secondary end points include progression-free survival, objective response, proportion of patients with symptom improvement, and the incidence of treatment-emergent adverse events.

Patients are required to be at least 18 years of age or older with an ECOG performance status of 0 or 1, have a life expectancy of at least 12 weeks, histologically or cytologically confirmed SCLC, and evaluable disease per RECIST v1.1 criteria. Patients are also required to have radiologically confirmed progression on or after first-line platinum-based chemotherapy, immunotherapy, or chemoradiation, as well as adequate bone marrow, hepatic function, and renal function.Patients with central nervous system metastases were allowed into the study given they met specific criteria.

In addition to SCLC, the irinotecan liposome injection is currently approved in the United States and in Europe in combination with fluorouracil and leucovorin as treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. However, the drug does not have an indication as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas. In June 2020, the irinotecan liposome injection was granted a Fast Track designation in combination with 5- fluorouracil/leucovorin and oxaliplatin as a potential treatment for patients with previously untreated, unresectable, locally advanced and metastatic pancreatic ductal adenocarcinoma. The phase 3 randomized NAPOLI-3 clinical trial (NCT04083235) is investigating the combination in study treatment-naïve patients with metastatic pancreatic cancer.

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_{Ipsen receives FDA Fast Track designation for investigational irinotecan liposome injection (ONIVYDE®) as a second-line monotherapy treatment for small cell lung cancer (SCLC). News release. Ipsen. November 30, 2020. Accessed December 1, 2020.}