Lonsurf gets a boost from FDA for colorectal cancer, challenging rivals Takeda and Hutchmed

Lonsurf Gets FDA Approval for Colorectal Cancer

Source – Taiho Oncology 

Eight years after initially gaining FDA approval for the treatment of heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has now secured another approval for the same indication, but this time as part of a more potent treatment regimen.

Instead of being used as a single-agent therapy, the FDA has cleared Lonsurf for use alongside bevacizumab in patients with previously treated metastatic colorectal cancer. Patients who have already undergone treatment with an anti-VEGF inhibitor, like bevacizumab (originally known as Avastin from Roche), may also be eligible for this new combination therapy.

The combination of Lonsurf and bevacizumab has proven to be more effective than using Taiho’s drug alone. In a group of patients who had received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux, the new combination significantly reduced the risk of death by 39% compared to Lonsurf monotherapy.

The FDA approval of this combination provides patients with mCRC an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population. Notably, the use of LONSURF plus bevacizumab in these patients did not result in an increase in potentially intolerable side effects that might limit the utility of this combination.”

– Marwan Fakih, MD, Professor, Medical Oncology and Therapeutics Research, City of Hope, Duarte, Calif., and lead US investigator for the pivotal Phase III SUNLIGHT trial that evaluated this combination

This approval was granted under the priority review pathway by the FDA. It comes at a time when Lonsurf is approaching competition from Takeda and Hutchmed’s fruquintinib in the treatment of colorectal cancer.

In a Phase III trial, patients who received the Lonsurf-bevacizumab combination lived a median of 10.8 months, while those in the Lonsurf-only group lived a median of 7.5 months.

Fruquintinib, on the other hand, has shown promise in reducing the risk of death by 34% compared to placebo in a group of colorectal cancer patients who have exhausted other treatments. However, it achieved this overall survival benefit in the FRESCO-2 trial in a population that had undergone more extensive prior treatments, including the use of Stivarga, Lonsurf, or a PD-1 agent from Bayer.

Hutchmed had released these data in the previous fall, leading Takeda to secure the rights to fruquintinib outside of China by providing $400 million upfront and up to $730 million in potential milestone payments. In China, the drug is already approved under the brand name Elunate.

The FDA has also given priority review status to fruquintinib’s application for colorectal cancer, with a target decision date set for November 30.

Apart from its application in colorectal cancer, Hutchmed is also pursuing Lonsurf’s indication for stomach cancer, having received positive results from a China Phase III study in the second-line setting. However, this study may not be sufficient to support FDA approval for Lonsurf in the United States due to the FDA’s position on China-only studies.

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