The Ministery of Food and Drug Safety has authorized domestic use of a new anticancer drug for patients with rare ovarian cancer who have limited treatment options. It is expected to offer a new choice for patients who no longer respond to standard treatment.
The Ministery of Food and Drug Safety said on the 19th that it approved the imported orphan anticancer drug Elahere injection (ingredient name mirvetuximab soravtansine). The drug is a treatment for patients with certain rare cancer groups, including high-grade serous epithelial ovarian cancer.
Elahere injection targets a protein called folate receptor alpha (FRα), which is highly expressed on the surface of cancer cells. FRα is notably present in certain ovarian cancer cells. The drug combines an anticancer agent that directly destroys cells with an antibody that recognizes FRα, delivering the drug selectively to cancer cells. This type of therapy is called an Antibody-Drug Conjugate (ADC).
The approved indication is for adult patients with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are FRα-positive and have developed resistance to platinum-based chemotherapy after receiving at least one and up to three prior lines of chemotherapy without benefit. Fallopian tube cancer and primary peritoneal cancer are clinically categorized the same as ovarian cancer due to similar treatment approaches and prognoses.
The Ministery of Food and Drug Safety said it designated Elahere injection as a target of the Global Innovative product Fast-track review support system (GIFT) and conducted an expedited review. GIFT is a system that provides regulatory support from early development so that treatments for life-threatening severe and rare diseases can be supplied to patients more quickly.
In addition, the Ministery of Food and Drug Safety authorized on the same day a companion diagnostic medical device that verifies FRα positivity in a patient's tumor to ensure Elahere injection is used safely and effectively. The test is used in advance to determine whether a patient qualifies for the treatment.
The Ministery of Food and Drug Safety said, "We will continue institutional support so that safe and effective treatments can be supplied more quickly to patients with serious diseases or rare diseases."