The Food and Drug Administration has given special status to a potential mesothelioma treatment in an effort to speed up the approval process.
The U.S. Food and Drug Administration (FDA) has granted fast-track status to a candidate biologic for the most common form of malignant pleural mesothelioma, which should provide an accelerated review process if subsequent trials confirm its safety and ability to prevent disease progression as an initial treatment, according to its developer.
Norwegian pharmaceutical maker Targovax announced on Feb. 15 that its injectable immunotherapy candidate ONCOS-102 — 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 given to products aimed at treating serious conditions that “fulfill an unmet medical need,” according to the agency.
Faster BLA?
Targovax also noted that products selected for fast-track status “are eligible for more frequent communication with regulatory authorities (including the new biologics license application), are provided opportunities to submit a rolling Biologic License Application,” which allows parts of the BLA to be submitted early to allow review as it is received. Marketing and shipping could only start if the BLA is approved.
The therapy relies on adenoviruses that are modified to render “tumors visible to the immune system” and induce the immune system to “recognize and destroy patient-specific tumor cells,” says the company.
The product is in early phase two testing as an add-on to the first standard of care for mesothelioma patients, a regimen consisting of pemetrexed and cisplatin (Alimta and Platinol).
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.
Though, incredibly not a drug, the potential therapy already had orphan drug status with the FDA — an important designation for candidate therapies indicated to treat rare diseases including mesothelioma.
The fast track-designation by the FDA marks a very important milestone for the ONCOS-102 program, stated in press release by the company. Importantly, this also confirms the high potential of ONCOS-102 as an emerging treatment option in a variety of solid tumors with significant unmet medical need and supports our plans for further clinical development at various sites internationally.
