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New Drug: Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer (SONAYA)

New Drug: Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer (SONAYA)
Study:
  • Single-arm, Phase-3 trial
  • Platinum-resistant epithelial ovarian cancer (up to three prior lines of systemic therapy; all patients were required to have received bevacizumab)
  • Mirvetuximab soravtansine at 6 mg/kg every 3 weeks (n=104)
Efficacy:
  • ORR: 31.7% [22.9 – 41.6]
  • mDoR: 6.9 mos [5.6 – 9.7 mos]
Safety:
  • Adverse reactions ≥20%: vision impairment, keratopathy, peripheral neuropathy, ALT and AST increased

Ursula A. Matulonis et al

Ursula A. Matulonis et al. Mirvetuximab Soravtansine-gynx for FRα-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-mirvetuximab-soravtansine-gynx-fra-positive-platinum-resistant

Reviewed by Elvin CHALABİYEV, MD on Jan 30, 2023

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