The U.S. Food and Drug Administration (FDA) has approved a new oral drug combination, Avmapki Fakzynja Co-Pack. This investigational treatment is focused on low-grade serous ovarian cancer (LGSOC), which is a rare, slow-growing form of cancer that primarily affects women. This exciting new therapy marries the best of both worlds by bringing together two powerful drugs, avutometinib and defactinib. It’s tailored especially for adult patients who have not responded adequately to other therapies.
Low-grade serous ovarian cancer, one of the rarer subtypes, is a model for how this could work and it’s estimated to affect only about 80,000 people worldwide. It particularly affects girls in their 20s-30s and women in their 50s-60s. In the United States alone, an estimated 6,000 to 8,000 women are now living with this diagnosis. The approval of Avmapki Fakzynja Co-Pack also provides an important new treatment path for these patients.
Avmapki Fakzynja Co-Pack is designed specifically for patients with LGSOC that are positive for the KRAS mutation. This mutation is present in about 30% of LGSOC tumors. You’ll be taking Avmapki twice a week and Fakzynja twice a day for three weeks. Then, revel in a blissful one-week intermission before launching into the next four-week circus! Patients can stay on this regimen as long as the drug continues to work and tolerable side effects are maintained.
Avutometinib works by blocking a specific protein that drives many cancers, called MEK. This protein is important to many cell signaling pathways that promote cancer proliferation. By inhibiting MEK, the opposite happens—another protein called FAK gets unleashed and becomes super-active. Defactinib then reverses this effect by blocking the FAK protein, thus stopping the cancer from building its defenses and growing resistant to treatment.
In clinical trials of Avmapki Fakzynja Co-Pack, remarkable tumor shrinkage was reported in 44% of participants. The response to the treatment was highly variable. In some patients, effects lasted as little as 3.3 months, while others continued to benefit for as long as 31.1 months. Together, these discoveries underscore the promise and mechanism of the innovative combo therapy. What’s more, it stands to provide tremendous value to patients battling this very difficult form of ovarian cancer.
Through this accelerated approval, Avmapki Fakzynja Co-Pack represents a significant advancement in the treatment of low-grade serous ovarian cancer. This approval highlights the critical need for new treatment alternatives for patients who are out of options.
Leave a Reply