Irinotecan Liposome Injection Gets FDA Fast Track Designation for Second-Line Small Cell Lung Cancer

FDA grants fast track designation to irinotecan liposome injection (Onivyde; MM-398) as second-line monotherapy for patients with small cell lung cancer whose disease progressed following a platinum-based chemotherapy regimen.

The FDA has granted a fast track designation to irinotecan liposome injection (Onivyde; MM-398) as second-line monotherapy option for patients with small cell lung cancer (SCLC) whose disease progressed following a platinum-based chemotherapy regimen.1

“The fast track designation of [irinotecan liposome injection] as a potential treatment for [patients] living with SCLC is an extension of Ipsen’s focus and contribution to the treatment landscape in oncology,” Howard Mayer, MD, executive vice president and head of research and development at Ipsen, stated in a press release. “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.”

In the open-label, 2-part phase 2/3 RESILIENT trial (NCT03088813), investigators are evaluating the safety, tolerability, and efficacy of irinotecan liposome injection monotherapy in patients with SCLC who progressed on or following a frontline platinum-based regimen. In part 1, investigators utilized dose-finding and -escalation analyses to identify the appropriate dose of the monotherapy; here, the primary end points were safety and tolerability. In part 2, which was initiated in September 2019, investigators evaluated the efficacy of this approach compared with standard-of-care topotecan. The primary end points for part 2 include progression-free survival and overall survival.

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