The Food and Drug Administration granted a Fast Track Designation to RC88 for platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers.
The Food and Drug Administration (FDA) granted a Fast Track Designation to RC88 for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers, according to a press release issued by RemeGen Co, the manufacturer of the drug.
Fast Track designations (FTDs) are granted to drugs that show promise in treating a serious condition or illness and can expedite the review of therapies to fill an unmet need.
“The FDA’s FTD accelerates the development and review process of RC88, which affirms our commitment to pioneering treatments that address the urgent needs of those facing challenging disease. Moving forward, RemeGen will continue to accelerate the development of its ADC products, with the aim of bringing more and better solutions to patients globally,” RemeGen’s CEO, Dr. Jianmin Fang, said in a press release.
RC88 is an antibody-drug conjugate, which is a type of drug that works by targeting and attaching to a certain protein on tumor cells to directly deliver anti-cancer drugs to the disease, rather than healthy cells around it. In this case, RC88 attaches to mesothelin (MSLN), a protein found on the cell surface that is associated with tumor burden, cancer stage and poor overall survival.
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For patients with epithelial ovarian cancer, the MSLN tends to be highly expressed in aggressive and later-stage disease. According to the press release, treatment options are limited for this patient population.
In late December 2023, the FDA also granted an Investigational New Drug approval for an international phase 2 trial evaluating RC88 in gynecologic cancers. The trial will investigate the optimal dosage, effectiveness and safety of RC88 in this patient population.
The main goal of the phase 2 trial is to evaluate the overall response rate (percentage of patients whose disease shrinks or disappears from treatment) at the 24-week mark. Researchers will also investigate progression-free survival (time from treatment until death or disease worsening), how the drug moves throughout the body, time to maximum concentration of RC88 within the body and how RC88 sparts an immune response.
“The approval of RC88’s IND application by the FDA marks a pivotal moment in our commitment to addressing the challenges of platinum-resistant recurrent ovarian cancer. Our focus remains on developing innovative treatments that can significantly improve patient outcomes in areas with critical unmet needs. RC88, with its unique targeting mechanism, exemplifies our dedication to pioneering advancements in cancer therapy,” Fang said.
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