Accelerated approval of avutometinib and defactinib offers new hope for U.S. patients with KRAS-mutated LGSOC

In a landmark decision, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for the first-ever treatment developed specifically for recurrent low-grade serous ovarian cancer (LGSOC).

The newly approved combination— avutometinib and defactinib —will be available in the United States under the commercial names AVMAPKI™ and FAKZYNJA™, co-packaged by Verastem Oncology. This treatment is approved for adult patients with recurrent LGSOC who have a KRAS mutation—a key genetic change found in roughly 40–50% of LGSOC cases.
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What Is a KRAS Mutation?
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KRAS is a gene that helps control how cells grow. When this gene is mutated, it can send signals that tell cancer cells to grow and spread. These mutations are common in several types of cancer, including LGSOC. Until now, there have been no FDA-approved treatments that specifically target KRAS-mutated low-grade serous ovarian cancer.
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How Do Avutometinib and Defactinib Work?

​These two medicines target different pathways involved in cancer cell survival:

• Avutometinib blocks part of the MAPK pathway, which KRAS mutations often rely on to promote cancer growth.
• Defactinib targets a protein called FAK, which helps cancer cells stick together and avoid dying.

Together, they work to interrupt the signals that help cancer cells survive and spread. In clinical trials, this combination showed promise in helping shrink or control tumors in some patients with KRAS-mutated LGSOC.
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What Is Accelerated Approval?
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​The FDA’s accelerated approval program allows promising treatments to reach patients more quickly, especially when there are no existing approved options. This approval is based on data from clinical trials showing strong early results. A larger confirmatory study— RAMP 301 —is already underway to gather more data about long-term benefit and to evaluate the treatment in patients without a KRAS mutation.
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What This Means for U.S. Patients
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​If you’re a U.S.-based patient with recurrent LGSOC and have tested positive for a KRAS mutation, this new treatment could now be an option for you. You’ll need to speak with your oncologist about:

• Whether you’ve been tested for KRAS mutations (and how to get tested if not).
• Whether this treatment might be appropriate for your case.
• How to access the medications and what insurance coverage may look like.

This approval only applies in the United States, and only for KRAS-mutated cases. But it marks a major step forward—and a validation of years of research, advocacy, and patient participation in clinical trials.
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Low-grade serous ovarian cancer is distinct from more common ovarian cancers. It tends to grow slowly but resists standard chemotherapy, leaving patients with few effective options. The approval of AVMAPKI and FAKZYNJA is a turning point in the treatment landscape—one that was made possible through research, advocacy, and patient participation in clinical trials.
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Learn more about the FDA approval

​Read Verastem’s full announcement here:
FDA Approves AVMAPKI and FAKZYNJA for KRAS-Mutated LGSOC

In 2021, my husband and I began infertility treatments after a year of trying to conceive. I had been diagnosed with Polycystic Ovarian Syndrome, though I did not have any cysts at that time. After three medicated cycles and two IUI cycles, we took a break from treatments and moved to a new state.

In October 2021 we found a new Infertility specialist who began running their own tests. A transvaginal ultrasound revealed that I had a mass on each ovary. Given my previous diagnosis, we monitored the masses for one cycle, hoping they would shrink, as hemorrhagic cysts often do. When they grew, my doctor ordered the CA-125 Cancer Antigen blood test, which came back 200x higher than normal. They referred me to a gynecologic oncologist for further consult and surgery.

In December 2021, after open abdominal surgery to remove the masses, my fallopian tubes, and other spots of potential metastasis,  I was diagnosed with Low-Grade Serous Ovarian Carcinoma, at age 29. Further tests and biopsies revealed the cancer had spread through the lymph nodes of my abdomen, chest and neck, making it Stage 4.

Over the next 3 months, I underwent an egg retrieval procedure and three additional surgeries to remove the infected lymph nodes, and complete the total hysterectomy. Thankfully, my surgeries had very good results, an optimal debulking.

After surgeries, I entered a clinical trial, which is aimed at studying the efficacy of chemotherapy on LGSOC, and was sorted into the branch of the trial receiving chemo and then maintenance medication. Six weeks after my final surgery, I began chemo with 6 cycles of carboplatin and taxol, once every 3 weeks.

Now, 2 and a half years later, I remain in good health, with no visible disease in my body. I have graduated to twice yearly scans (down from 4), though I still receive bloodwork 4x annually. My maintenance medication of Letrozole seems to be keeping the cancer away.

I am back to work, even planning to start a business with my husband. We are awaiting an adoption match, and taking every opportunity that comes our way to travel and spend time with those we love. I volunteer by sharing my story with medical students, and raising funds for Ovarian Cancer Awareness month and various other events.

I have Survived, so I choose to Thrive, Advocate and Advance Research along with wonderful organizations like STAAR. 

At STAAR, we believe in the power of sharing personal journeys to inspire and connect our community. This month, we highlight the story of our board chair, Nicole Andrews, and invite you to share your own story to foster hope and awareness.

In May 2020, Nicole was diagnosed with low-grade serous ovarian cancer (LGSOC). Despite undergoing chemotherapy during the pandemic, she organized a 5K for Ovarian Cancer Awareness Month that September, raising $25,000.

“I didn’t know the symptoms associated with ovarian cancer and assumed those I was having (menstrual irregularities, indigestion, fatigue) were linked to other things like perimenopause, not sleeping well, etc.,” she said.

Now, as a retired associate professor from the University of Houston and STAAR’s board chair, Nicole is dedicated to spreading awareness and supporting others facing LGSOC.

Read More Stories of Hope

Share Your Journey
There’s power in sharing your story. It can spark connection, raise awareness, and offer hope to someone facing a similar path. If you’ve been impacted by LGSOC—as a patient, caregiver, supporter, or friend—we’d love to hear from you.

Your story could be featured on our website, social media, or in future newsletters to inspire and empower others in our community.

Submit Your Story

When I was diagnosed with low-grade serous ovarian cancer (LGSOC) in the fall of 2022 it stopped me in my tracks. I was working at a job I enjoyed and found interesting (a rarity, I know). I was happily married to my high school sweetheart and we had a nice quiet life with our beloved cockapoo.

Unfortunately, all of my current and future plans got turned upside down after being diagnosed with LGSOC. It took a while for things to sink in about how much my life was going to change. As I went through treatment, including surgery, chemo, and a maintenance drug, I sometimes felt powerless against this disease. 

While I recovered and felt better, I had more capacity to research LGSOC. I learned how it is extremely under researched and underfunded, which are two things you never want to hear about your cancer type. I immediately became more frustrated and motivated to do something to try and help.

During my late night internet searching, I thankfully found STAAR. I was thrilled to find an organization dedicated to LGSOC and even more elated that they focused on raising funds for research and spreading awareness. I knew right away I had found a special group of people who truly understand what it is like to live day in and day out with this disease. 

All of the board members and volunteers welcomed me into STAAR as I began volunteering with the Marketing and Communications Committee. I was able to apply my skills and past experience working in health education to create patient outreach materials and social media posts.

I told my story as I testified at the FDA externally-led patient-focused drug development meeting and described what life is like living with LGSOC. Recently, I was part of the planning committee for the inaugural LGSOC patient conference. I was honored to join STAAR’s board in December 2024 and lead future volunteer efforts.

I found that volunteering has been a healthy way to channel some of my frustrations and negative thoughts into tangible actions. I know I am using my time and energy toward a worthwhile cause and I am doing that alongside an amazing group of people.

We are always looking for people to join us as volunteers. It’s incredible what we can do when we do it together. 

STAAR is powered by dedicated volunteers—patients, caregivers, and advocates who want to make a difference.

Whether you’re passionate about research, fundraising, communications, or donor relations, there’s a place for you on our team.
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• Flexible commitment levels (1-20 hours per week)
• Meaningful ways to contribute to the LGSOC community
• Work alongside inspiring leaders & researchers

You can fill out the interest form here.

Meet Staarla, Our Shining Star!

We also have a snazzy new look, thanks to a generous donation from Duo Collective through their Duo Gives Back program

We're excited to introduce our mascot, Staarla! This friendly star represents hope, resilience, and the power of community. Big changes deserve a little extra sparkle! Keep an eye out for her in emails, social media, and special STAAR materials.

Staarla is here to remind you that you're never alone.
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Last weekend, STAAR hosted the first LGSOC Patient Conference in Houston, creating an opportunity for people with low-grade serous ovarian cancer to gather together and hear from leading researchers. For many, it was the first time meeting another person with low-grade face to face.

Jennifer Davis Zeimen was diagnosed with LGSOC years before STAAR existed. 

She writes:
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STAAR was created 5 years ago. Before then, I didn’t know of any group or charity focused on my rare cancer, LGSOC. I (and many others facing LGSOC) had a lot of lonely years. Three strong women created STAAR, which raises funds exclusively for research of our disease that is so lacking in effective treatments. 

Last weekend I was so lucky to attend STAAR’s first ever patient conference. For the first time in 9 years I met other people with LGSOC and got to hear about the latest research. Luke got to connect with other husbands (and caregivers). We learned, and laughed, and cried, and felt overwhelmingly grateful. 
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Originally published on Future of Personal Health

A rare cancer diagnosis is a lonely thing. For those of us with low-grade serous ovarian cancer (LGSOC), the pain of isolation is amplified by a poor prognosis, knowing there are no specialized treatments for our disease.

In 2018, Jessica BeCraft’s cancer was discovered during an unplanned C-section for her daughter, Harper. At the time, she thought, “Low-grade means it must be early. I’m sure I’ll be fine.”

She would learn that “low-grade” does not refer to the severity of the disease, but rather the type of cells, which are slow-growing and persistent. Unfortunately, this slower growth makes LGSOC harder to treat because it often doesn’t respond to the drugs that target other ovarian cancers.

Discouraged by the lack of treatment options and research funding, in 2020, Jess brought together two other women with LGSOC to create the first nonprofit in the United States dedicated to improving outcomes for the disease — STAAR Ovarian Cancer Foundation. The acronym stands for “Survive. Thrive. Advocate. Advance Research.”

Creating more optimistic outcomes for others
Jess’s cancer was not caught early. It was stage 3C. She knew she might not survive long enough to benefit from research funded by STAAR, but she was committed to improving the prognosis for others. 

Jess BeCraft passed away at age 37 in September 2021. Another of the co-founders, Alexandra Feldt, died a year earlier at age 34. The third, Bailey Wolfe, serves on STAAR’s all-volunteer board, which includes five other women with LGSOC.

What started with birthday fundraisers and a virtual Turkey Trot during the pandemic grew into a community where no one with LGSOC has to feel alone in their diagnosis.

In addition to contributing more than $600,000 so far to LGSOC research at leading institutions, STAAR has advanced understanding of the disease in collaboration with other organizations, including Cure Our Ovarian Cancer and the World Ovarian Cancer Coalition.

Last year, those partnerships led to the first-ever ovarian cancer patient meeting with the FDA and the first global survey about the patient impact of LGSOC.

A major takeaway from both is that although the cancer is rare, many have similar stories. The survey found that 99% of people had never heard of LGSOC before being diagnosed with it, and on average, it took nearly three years to get an accurate diagnosis. 

Delayed diagnoses and improving education
Like other ovarian cancers, LGSOC has no early detection test and is frequently diagnosed in later stages because of a general lack of awareness about the most common symptoms, which can include bloating, changes in bowel and urination habits, menstrual irregularities, and back pain.

Another challenge that’s delaying diagnoses is that LGSOC affects a younger demographic. Half of diagnoses occur before age 45. Two-thirds of the women surveyed said their healthcare providers initially dismissed their symptoms. Many diagnoses were delayed because of a misconception that 20 or 30 is too young to have ovarian cancer.  

This younger age range means most people with LGSOC are premenopausal. Low-grade serous cells have been found to be estrogen-sensitive, so many patients take a hormone blocker to try to slow or prevent cancer growth. These women are thrust into menopause decades ahead of their time, which affects fertility and libido. LGSOC literally steals years from their lives.

The low-grade community brought this to the attention of the federal agency responsible for evaluating new drugs during the patient meeting led by STAAR Board Chair Nicole Andrews.
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“Our stories, experiences, and advocacy during the meeting served as a powerful catalyst,” Andrews said. “It brought attention to the urgent need for a deeper understanding of the challenges faced by those with low-grade serous ovarian cancer.” 

A year ago this week, we held the first patient-focused drug development (PFDD) meeting for LGSOC with the FDA. Not only was this a first for LGSOC but a first for ovarian cancer overall.

One of the FDA’s missions is to protect and promote public health by evaluating the safety and effectiveness of new drugs, biologics, and devices. The FDA does not develop drugs nor conduct clinical trials. The FDA does, however, play a constructive role in guiding, helping, or evaluating the pre-clinical, translational, and clinical development work of potential new medications.

The PFDD meeting gave the LGSOC community an opportunity to share their views and stories with the FDA, including the importance of developing and bringing more therapies to patients. STAAR partnered with Cure our Ovarian Cancer and World Ovarian Cancer Coalition on this meeting and the outcome of the meeting was a clear roadmap for what needs to improve.

The information obtained at the meeting and summarized in this report is anticipated to lead to more dialogue between stakeholders in the LGSOC community, with the goal of gaining patients’ perspectives on their condition and therapies available to treat the condition to aid in decision-making for drug development and clinical trials for LGSOC, to ultimately improve the overall quality of life for patients.

At a high level, what the meeting found are the following areas of need:

• Education and awareness of LGSOC amongst healthcare professionals 
• FDA-approved treatments for LGSOC, including more research
• Better education about the side effects of aromatase inhibitors 
• Communication about sexual health with healthcare professionals or caregivers
• Early detection tools and tests for diagnosis before symptoms start 
• Noninvasive treatment options

Thank you to everyone who shared their stories and participated in the meeting. A year after the meeting, STAAR continues to make significant strides in addressing the awareness, research and support needs in LGSOC.
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September is Ovarian Awareness Month, which means it’s time for STAAR’s Step Up America Campaign, the most impactful awareness and fundraising program we execute together all year. It is our biggest fundraiser, where we bring in the vast majority of our donations.

Why do we need more awareness and funding for LGSOC?

We know from hearing from STAAR members and the landmark survey of 180 people across 10 countries that we were part of in 2023 that while we are making progress, we need to keep up the momentum of awareness, research and support. This survey alone found that for the majority of patients it took an average of nearly three years to get an accurate diagnosis, with many experiencing misdiagnoses or having their symptoms initially dismissed by a healthcare provider. And there are still no FDA approved medicines specific to LGSOC.

What has STAAR accomplished with the help of fundraising?

Since STAAR’s founding in 2020, we have made major strides in connecting the LGSOC community in the United States and with our partners globally.

• We helped to fund significant research focused on LGSOC.
• We established an LGSOC Awareness Day during Ovarian Cancer Awareness Month to focus attention on this rare cancer.
• We led the first FDA patient meeting about LGSOC, which educated the federal agency about the patient impact of the disease as they make decisions about potential new treatment options.
• We partnered with the World Ovarian Cancer Coalition and Cure Our Ovarian Cancer and experts around the world in the first global survey about the patient impact of LGSOC.
• We have raised awareness locally and nationally about LGSOC and the importance of symptom awareness through grassroots events and major media coverage.
• Most importantly, we have formed a community where no one with LGSOC has to feel alone in their diagnosis.

None of this could have happened without the contributions of our founders, our Board, our volunteers, our industry partners and family, friends and others living with LGSOC who have donated their time or funding to help our progress.
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Why should I get involved?
In order to make more progress against LGSOC and to support those living with it, significantly more research and awareness is needed. STAAR is the first advocacy group in the United States to focus on LGSOC by funding research to provide better outcomes, and offering resources and a place to connect. And STAAR is 100% volunteer-run, meaning more of every dollar goes directly to the mission.
 
How can I provide support?
Fundraising, Donations, Employer Matches and Volunteering, including our Step Up campaign, which is in full swing for September, at any level are all deeply appreciated.
 
Throughout the month, we support individuals in creating their own events to fundraise for research and spread awareness about LGSOC symptoms. We welcome events as large as a city-wide 5K and as small as a group of friends getting together for coffee. This year we also have the virtual Step Up America Step Challenge, creating an easy way to participate for those who can't host an event!

All participants can also order a Step Up T-Shirt with common LGSOC symptoms on the back to help spread awareness!
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