Photo: Takeda sign outside the California office/iStock; JHVE Photo
The FDA on Wednesday approved Takeda Pharmaceutical’s fruquintinib for adult patients with previously treated metastatic colorectal cancer. Oral targeted therapy for VEGF-1, -2, and -3 receptors carries the brand name Furuzakura.
Full Sakura-san label Patients previously treated with fluoropyrimidine, oxaliplatin, irinotecan chemotherapy, and anti-VEGF agents are eligible. In wild-type RAS metastatic colorectal cancer (mCRC), this therapy is also indicated for patients who have previously received anti-EGFR therapy, if medically appropriate.
Wednesday’s approval comes more than 20 days before the planned target action date, and Takeda said in a statement that Fluzakura is “approved in the U.S. for previously treated mCRC, regardless of biomarker status.” “The first and only selective inhibitor of all three VEGF receptor kinases”.
“Fluzakura is the first new chemotherapy-free treatment option approved for patients in the United States in more than a decade, regardless of biomarker status,” said Takeda, President of Global Oncology Business Unit. Teresa Vitetti said in a statement. “Furuzakura has the potential to provide significant survival benefits without negatively impacting patients’ quality of life.”
Furuzakura is an oral inhibitor of VEGF-1, -2, and -3 receptors, which together play an important role in the formation of blood vessels that sustain tumors, and is effective for sustained inhibition while minimizing off-target effects. , with strong selectivity allowing for high doses. of that target.
FDA approval is based on data from the Phase III FRESCO-2 and FRESCO studies. fresco-2a multiregional, randomized, double-blind, placebo-controlled study, showed significantly better survival for patients treated with Fluzacra. frescoa similar study conducted in China similarly demonstrated excellent overall survival and progression-free survival after FRUZACRA treatment.
Fluzakura does not come with a warning on the box, but it does list precautions against high blood pressure, infections, liver toxicity, bleeding events, and other potential side effects.
Wednesday’s regulatory victory ends a losing streak for Takeda, which has suffered both clinical and court defeats in recent months.
In September 2023, the U.S. Court of Appeals ruled that Genentech’s hemophilia A drug Hemlibra (emicizumab) did not infringe protections held by Takeda subsidiary Baxalta, leading to Takeda’s patent lawsuit with Roche. Lost the case.
Last month, the company was forced to withdraw its lung cancer drug Exquivity (mobocertinib) from the U.S. and global markets after it failed to meet its primary endpoint in a confirmatory Phase III trial.
Additionally, in its recent third-quarter earnings report, Takeda took more than $770 million in writedowns and lowered its fiscal 2023 outlook by 71%.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Please contact tristan@tristanmanalac.com or tristan.manalac@biospace.com.