The Food and Drug Administration has granted a potential mesothelioma treatment special status to hasten its approval process.

A candidate biologic for first-line treatment of malignant pleural mesothelioma — the most common form of the deadly disease — has been given fast track-status by the FDA, according to the product’s developer.

Norwegian pharmaceutical maker Targovax announced Feb. 15 that it’s injectable immunotherapy candidate ONCOS-102 — which is still in clinical trials — was granted this special status by the agency, which expedites the approval process, typically a multi-year affair. Fast track is granted to products aimed at treating serious conditions and that “fulfill an unmet medical need,” according to the agency.

Faster BLA?

Targovax added that fast tracked products “have improved likelihood of receiving priority review for a future Biologics License Application (BLA) and may be allowed to submit parts of the application early to shorten review time.” An approved BLA would allow the company to begin marketing and shipping the treatment.

The treatment is based on adenoviruses that have been engineered to make “tumors visible to the immune system” and to teach the immune system to “recognize and attack patient-specific tumor cells,” according to the company.

The product is currently in phase 2 trials as a complement to the initial standard of care for mesothelioma patients: a chemotherapy course of pemetrexed and cisplatin (marketed under the brand names of Alimta and Platinol, respectively).

Results Show Promise

According to Targovax, an 18-month analysis of the clinical trial shows that patients taking ONCOS-102 in concert with pemetrexed and cisplatin live an average of four months longer than those just taking the standard chemotherapy: 18.2 months versus 14.2 months. Sometime in the first half of 2021, the company is expected to release updated survival data from the ongoing clinical trials.

The potential therapy was previously designated an orphan drug by the FDA — despite it not actually being a drug — a status granted to candidate therapies for rare diseases, such as mesothelioma.

The company hailed the FDA’s fast track-designation as “a very important milestone for the ONCOS-102 program. Most importantly, fast track validates the strong potential of ONCOS-102 as a future treatment option for solid tumors with high unmet medical need.”

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