The US Food and Drug Administration (FDA) has granted accelerated approval to Verastem Oncology’s oral combination therapy for adults with a rare form of ovarian cancer.
Avmapki Fakzynja co-pack (avutometinib capsules; defactinib tablets) has been authorised to treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) in patients who have received prior systemic therapy, making it the first medicine approved by the regulator for this disease.
Approximately 6,000 to 8,000 women in the US are living with LGSOC, which is highly recurrent and less sensitive to chemotherapy compared to high-grade serous ovarian cancer, the most common type of ovarian cancer. It occurs more frequently in younger women and has a median survival of approximately ten years.
Verastem’s president and chief executive officer of oncology, Dan Paterson, said the approval of Avmapki Fakzynja “represents not only the first-ever FDA-approved treatment specifically for this rare cancer but also a new day for people living with this disease who have been in desperate need of new treatment options”.
“We are very proud to bring two innovative medicines in one combination treatment to the LGSOC community,” he added.
The FDA’s decision was based on results from the mid-stage 201 trial, in which 57 adults with measurable KRAS-mutated recurrent LGSOC were given Avmapki 3.2mg twice weekly for the first three weeks out of a four-week cycle and Fakzynja 200mg twice daily for the first three weeks out of a four-week cycle until disease progression or unacceptable toxicity.
The combination was associated with a confirmed overall response rate of 44%, with the median duration of response ranging from 3.3 to 31.1 months.
In line with the regulator’s accelerated approval programme, which expedites the approval of drugs that treat serious conditions and fill an unmet need, continued authorisation for Avmapki Fakzynja in this indication may be contingent on the verification and description of clinical benefit in a confirmatory trial.
Nicole Andrews, chair of the STAAR Low-Grade Serous Ovarian Cancer Foundation, said: “… we’re celebrating a milestone with the first-ever FDA-approved treatment option specifically for patients with recurrent LGSOC with a KRAS mutation.
“The LGSOC community is hopeful and excited about the potential benefits of this treatment and the progress toward improving the diagnosis, awareness and research for LGSOC.”
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