Normally, Fast Track is an FDA process designed to facilitate and expedite the development and review of drugs or biologics intended to treat rare or serious conditions. Recently, Healio shared that IN10018, a therapy for patients with platinum-resistant ovarian cancer, received Fast Track designation from the FDA.
So what exactly is IN10018? According to a press release from drug developer InxMed, IN10018 is:
A potent and selective ATP-competitive FAK inhibitor [which] has demonstrated a favorable safety profile and promising efficacy signals against a number of tumor types. Emerging science also showed that FAK inhibitors, like IN10018, potentially overcome fibrotic barrier and immune tolerance.
Because of this, the treatment could have increased effectiveness when used in conjunction with the current standard-of-care (chemotherapy).
As described above, the treatment received Fast Track designation. The FDA explains that this status is:
Based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.
Alongside this designation, InxMed will receive more frequent FDA meetings and communication, Rolling Review, and eligibility for Priority Review and Accelerated Approval if certain conditions are met.
Ovarian cancer forms in the ovaries, which are almond-shaped organs on each side of the uterus which store eggs and produce hormones. While the cause of ovarian cancer is widely unknown, some patients have BRCA gene mutations. In fact, those with these mutations are 10-30x more likely to develop ovarian cancer than those without. Ovarian cancer has a variety of subsets, including small cell carcinoma of the ovary, stromal carcinoma tumors, epithelial tumors, and germ cell carcinoma tumors. Symptoms include:
- Appetite loss
- Tender breasts
- Abnormal uterine bleeding or vaginal discharge
- Changes in urinary urgency or frequency
- Abdominal swelling
- Increased testosterone
- Menstrual irregularities
- Pelvic pain