AbbVie Secures Full FDA Approval for ADC Elahere in Ovarian Cancer

2024-03-25

临床3期免疫疗法临床结果上市批准引进/卖出

Pictured: AbbVie's building in South San Francisco, California/iStock, vzphotos The FDA on Friday granted AbbVie’s antibody-drug conjugate Elahere (mirvetuximab soravtansine-gynx) full approval for the treatment of certain ovarian, fallopian tube and primary peritoneal cancer patients. Friday’s full approval makes Elahere the “first and only antibody-drug conjugate (ADC) approved in the U.S. for” ovarian cancer, a “difficult-to-treat malignancy,” AbbVie CMO of global therapeutics Roopal Thakkar, said in a statement. The conversion to full approval was supported by data from the confirmatory Phase III MIRASOL study, which enrolled 453 patients and compared Elahere against an investigator’s choice of chemotherapy. The study focused on patients with platinum-resistant ovarian cancer whose tumors had high levels of folate receptor alpha (FRα). All participants had been exposed to up to three previous lines of therapies. Results showed that Elahere could cut the risk of death by 33% relative to chemotherapy, as well as reduce the likelihood of cancer progression by 35%. Both effects were statistically significant, according to AbbVie’s announcement. In terms of safety, MIRASOL found Elahere to be more tolerable than chemotherapy, inducing a lower rate of dropouts due to side effects. The most common adverse events were fatigue, nausea and diarrhea, as well as increased enzyme levels. Kathleen Moore, principal investigator of MIRASOL, said in a statement that Elahere was the “first treatment to show a statistically significant overall survival benefit in platinum-resistant ovarian cancer. The approval provides a new effective treatment option for patients with FRα-positive cancers, who previously had “very limited options,” Moore added. Originally developed by Massachusetts-based biotech ImmunoGen, Elahere is a first-in-class ADC that works by seeking out and binding to the FRα protein, which is typically highly expressed in ovarian cancers. The ADC also carries the toxic maytansinoid payload DM4, which inhibits the polymerization of tubulin inside the cancer cells and triggering their death. Elahere won the FDA’s accelerated approval in November 2022 for the treatment of adults with FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancer FRα-positive, platinum-resistant ovarian, fallopian tube and primary peritoneal cancer who had been treated with up to three prior lines of systemic therapies. In November 2023, AbbVie bought ImmunoGen for $10.1 billion, gaining access not only to Elahere but also to ImmunoGen’s deep pipeline of ADCs being developed for various cancers, including acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. Friday’s full approval will boost AbbVie’s cancer business, which in 2023 suffered a 10% sales drop versus the year prior. AbbVie’s B-cell cancer therapy Imbruvica (ibrutinib) contributed heavily to this decline, earning $3.5 billion in 2023, a 21% revenue hit from 2022. Also poised to help AbbVie’s cancer business are its recent agreements with Umoja Biopharma. The pharma in January 2024 signed two exclusive option and license contracts with Umoja to advance multiple cancer CAR-T therapies, with total aggregate payments that could reach up to $1.44 billion. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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