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The Institute of Cancer Research Announces FDA Approval of First Therapy for Low-Grade Serous Ovarian Cancer

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Jun 2, 2025, 09:10

The Institute of Cancer Research Announces FDA Approval of First Therapy for Low-Grade Serous Ovarian Cancer

The Institute of Cancer Research shared a post on LinkedIn:

“NEW: The FDA has granted accelerated approval for the combination of avutometinib and defactinib, marking the first approved therapy for low-grade serous ovarian cancer – a rare and historically hard-to-treat cancer.

This milestone is the result of years of collaborative research, moving from lab discoveries at the ICR to global clinical trials at the Royal Marsden NHS Foundation Trust.

Professor Udai Banerji, Co-Director of Drug Development at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, who led the preclinical and clinical development of the drug combination that led up to the FRAME trial, said:

‘We used findings from multiple experimental approaches including the study of phosphoproteins and use of cancer cells from patients grown in the labs called ‘organoids’ to devise this combination.’

Many combinations of such drugs fail due to excessive side effects, we used learnings from previous trials of these drugs to design a highly intermittent schedule of delivering the drugs, which made the treatment tolerable”.

Professor Susana Banerjee, Consultant Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden NHS Foundation Trust and Professor in Women’s Cancers at The Institute of Cancer Research, who led the global phase two RAMP 201 study and is now spearheading the randomised phase three study, said:

‘This wouldn’t have been possible without the patients who took part in our clinical trials. Their contributions made this approval possible. The work continues with new studies underway to expand treatment options and reach more patients around the world.’

This approval marks a huge step forward, not just for ovarian cancer, but for what’s possible when research and clinical care work hand in hand.

Professor Banerji was an NIHR (National Institute for Health and Care Research) Research Professor in the joint Drug Development Unit at the ICR and The Royal Marsden working on combination therapy to overcome drug resistance at the time of the FRAME trial.

Read more here”

Proceed to the video attached to the post.

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The Institute of Cancer Research Announces FDA Approval of First Therapy for Low-Grade Serous Ovarian Cancer

‘We used findings from multiple experimental approaches including the study of phosphoproteins and use of cancer cells from patients grown in the labs called ‘organoids’ to devise this combination.’

‘This wouldn’t have been possible without the patients who took part in our clinical trials. Their contributions made this approval possible. The work continues with new studies underway to expand treatment options and reach more patients around the world.’