FDA to Speed Up Review of Novel Drug for Mesothelioma Not Treatable by Surgery

The Food and Drug Administration (FDA) recently granted the investigational drug IK-930 a fast track designation for potential use in patients with unresectable, NF2-deficient malignant pleural mesothelioma, according to Ikena Oncology, the developer of the novel therapy.

Fast track designations speed up the process by which the FDA reviews a promising treatment. The goal is to quicker fill unmet needs in the treatment landscape for the patients who need them most.

NF2-deficient malignant pleural mesothelioma is found in approximately 40% of patients with the disease. A combination of standard-of-care options, including surgery, chemotherapy, immunotherapy and radiation are often used in the treatment of this patient population. This fast track designation, however, is for patients with unresectable disease, meaning surgery is not an option.

If there is enough supportive clinical data, the experimental drug may be eligible for a priority review from the FDA. Of note, a priority review designation typically means that the FDA will decide to approve a drug or not within a six-month timeframe. That time period is a reduction of the usual 10 months the agency takes before it potentially greenlights a drug for public use.

Currently, there is an ongoing early-phase clinical trial evaluating the safety, tolerability and preliminary efficacy of IK-930 in more than 150 patients with advanced solid tumors with or without gene alterations in the Hippo pathway for whom there are no further treatment options known to confer clinical benefit.

In the trial, the experimental drug is being given as a single agent to patients, including those with NF2-deficient malignant mesothelioma.

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