On November 14, 2022 the FDA granted accelerated approval of mirvetuximab soravtansine-gynx (Elahere, ImmunoGen, Inc.) and antibody drug conjugate. (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant) . Women who have received one to three prior treatments and have folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer can receive the drug. The FDA also approved the companion assay device (VENTANA FOLR1 (FOLR-2.1) RxDx Assay ) for determining folate receptor alpha (FRα). The device is made by Ventana Medical Systems, Inc.
The approval was based on the results of the SORAYA Study NCT04296890), a single-arm trial of 106 women who had up to three other treatments and also received bevacizumab. Patients who had ocular, corneal, grade 1 neuropathy or lung infection issues were excluded. The Overall Response Rate (ORR) was 31.7% and median Duration of Response (DOR) was 6.9 months.
Women who are given the drug will receive a dose of 6 mg/kg adjusted ideal body weight every 3 weeks by IV. I wondered what adjusted ideal body weight was, so I found this formula for calculating it. Adjusted body weight(ABW) = Ideal Body Weight(IBW) + 0.25 * (ABW - IBW) Source: (https://pubmed.ncbi.nlm.nih.gov/22836946/)
Some side effects women in the study experienced included vision
impairment, fatigue, nausea, abdominal pain,
peripheral neuropathy, diarrhea, decreased
albumin, constipation, dry eye,
decreased magnesium, etc. There is a warning for
ocular toxicity. You may learn more at https://ascopost.com/issues/december-10-2022/fda-grants-accelerated-approval-to-mirvetuximab-soravtansine-gynx-for-fr-positive-platinum-resistant-epithelial-ovarian-fallopian-tube-or-peritoneal-cancer/ .
I often wondered how fast drug approval translates into actual use in the clinic. It has been one month since the approval took place. The following is anecdotal information but I thought it was interesting enough to share. In that one month's time, I have offered peer support to three women dealing with recurrent ovarian cancer. Two of those women brought up to me that their oncologists told them about the new drug "with the very long name". It seems like no one called it , Elahere. One has been already tested to see if she was folate receptor alpha (FRα) positive. One was told about it but will continue with her current treatment which is going well for her. But she was happy to have another option for the future. One did not mention the new drug during our conversation.
In the ASCO Post Article noted above Ursula A. Matulonis, MD, Chief of the Division of
Gynecologic Oncology and the Brock-Wilson Family Chair at Dana-Farber
Cancer Institute and co-leader of the SORAYA study stated “There have been no
approved therapies for platinum resistant ovarian cancer since 2014, so
[this] action by the FDA is a very significant milestone.” I agree and I am happy to see how quickly oncologists are sharing the information about the drug with the patients.
Dee
Every Day is a Blessing!
