Elahere® (Mirvetuximab Soravtansine-gynx): The First-in-Class FRα-Targeted ADC Receives Full FDA Approval for Platinum-Resistant Ovarian Cancer
Huadong Medicine
Large Comprehensive Pharmaceutical Product Developer
Huadong Medicine
Comprehensive pharmaceutical manufacturer
AbbVie
Innovative Drug Developer
On March 25, Huadong Medicine Co., Ltd. announced that ELAHERE® (mirvetuximab soravtansine injection) from its wholly-owned subsidiary Huadong Medicine's U.S. partner AbbVie Inc. has received full approval from the U.S. FDA.For the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy.
The announcement shows that ELAHERE® (mirvetuximab soravtansine injection) is a first-in-class drug globally and also the first and only ADC drug approved in the United States for the treatment of this malignant tumor, pioneering a new approach for ovarian cancer treatment. This marks that the treatment of PROC (platinum-resistant recurrent ovarian cancer) has entered the ADC era.
ELAHERE® is an ADC drug targeting folate receptor α (FRα, a cell surface protein highly expressed in ovarian cancer), composed of an FRα-binding antibody, a cleavable linker, and the maytansine derivative DM4.
Huadong Medicine Co.,Ltd. acquired from ImmunoGen, Inc. in October 2020 (Currently acquired by AbbVie, ELAHERE® has been introduced, obtaining exclusive clinical development and commercialization rights for ELAHERE® in Greater China (including mainland China, Hong Kong, Macao, and Taiwan).。
On May 23, 2022, ImmunoGen announced that the U.S. FDA had accepted the Biologics License Application (BLA) for this product and granted it priority review. On November 15, 2022, ImmunoGen announced that the product had received accelerated approval from the U.S. FDA for marketing.
According to the announcement, the conversion of ELAHERE® from accelerated approval to full approval this time is based on confirmatory evidence.Phase III Clinical Trial MIRASOL. This trial is a randomized trial comparing the efficacy and safety of ELAHERE® with investigator's choice (IC) single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan) in patients with platinum-resistant ovarian cancer. The data showed that Elahere treatment provided an OS benefit.Compared with the IC chemotherapy group, the risk of death in the ELAHERE® group was reduced by 33%, and the risk of cancer progression was reduced by 35%.Compared with the IC chemotherapy control group, the ELAHERE® group had fewer Grade 3 and above adverse events overall, and a lower rate of discontinuation due to adverse events.
With its excellent efficacy, ELAHERE® has achieved a strong start right after its market launch. According to ImmunoGen's Q3 financial report for 2023, ELAHERE®'s net sales in the U.S. for the third quarter reached $105.2 million, with cumulative sales for the first three quarters amounting to $212 million, far exceeding the forecast of $62 million for its global total sales in 2023. Galaxy Securities estimates that its first-year sales may exceed $500 million.In fact, there are currently five ADC drugs targeting FRα that have entered clinical trials or have been approved for marketing globally, and ELAHERE® is the only marketed product.
Notably, in July 2023, ELAHERE® was included in the priority review list by the CDE. In October 2023, the marketing authorization application for ELAHERE® in China was accepted by the NMPA and is currently under review.
In July 2023, under the support of the "pilot first" policy in Boao Free Trade Zone in Qionghai City, Hainan Province, ELAHERE® was prescribed for the first time in China at the Hainan Hospital of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. This marked the introduction of a new drug for PROC (platinum-resistant ovarian cancer) treatment into China. In August 2023, a real-world study for platinum-resistant ovarian cancer was officially launched at Boao Ruijin Hospital in Hainan. Additionally, Huadong Medicine plans to participate in an international multicenter PSOC (platinum-sensitive ovarian cancer) clinical trial to advance the product's frontline treatment for ovarian cancer and support ELAHERE® as a combination therapy for ovarian cancer.
