The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
Pictured: FDA sign in front of brown brick buildings/iStock, hapabapa
The FDA on Wednesday approved Taiho Oncology’s Lonsurf (tipiracil) as part of a combination regimen with Roche’s Avastin (bevacizumab) for the treatment of metastatic colorectal cancer.
Lonsurf picked up its first approval in September 2015 as a monotherapy in this indication. Wednesday’s label expansion covers patients who had previously been treated with an anti-VEGF biologic agent and fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
Patients harboring the wild-type RAS protein and had previously received an anti-EGFR therapy are also eligible for the newly approved combination regimen.
Lonsurf’s latest approval “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,” Marwan Fakih, lead investigator on the SUNLIGHT trial, said in a Taiho statement.
SUNLIGHT, a Phase III, randomized, open-label and global trial, supported the FDA’s decision. Compared with Lonsurf monotherapy, the combination regimen led to a significant improvement in overall survival, reducing the risk of death from any cause by 39%. Patients who received the combo treatment also saw significantly better progression-free survival.
The Lonsurf-Avastin combo also significantly slowed functional decline. In patients receiving the investigational regimen, ECOG performance status worsened from a score of 0 or 1 to 2 or more over a median duration of 9.3 months. In comparators given Lonsurf monotherapy, the same deterioration occurred over only 6.3 months.
In terms of safety, the combination regimen had a manageable adverse event profile. Its most common severe treatment-emergent toxicity was neutropenia.
With Wednesday’s approval, Taiho has edged out Takeda and Hong Kong-based collaborator Hutchmed, which in March 2023 announced that it had completed its rolling New Drug Application for fruquintinib, also being developed for mCRC. In May, the FDA gave its Priority Review designation to the application and is set to come to a decision by November 30.
Fruquintinib was discovered and was originally being developed by Hutchmed but in January 2023 Takeda bought into its promise, dropping $400 million upfront and pledging up to $730 million in additional payments for an exclusive worldwide license to develop and commercialize the candidate outside the greater China region.
Takeda and Hutchmed are also trialing fruquintinib in the second-line setting for gastric cancer, for which Lonsurf won the FDA’s approval in February 2019.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
