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ONCOFID-P Was Given Orphan Drug Status to Treat Pleural Mesothelioma

Published: August 6, 2021

Pleural mesothelioma could soon have a new approved treatment option. The Food and Drug Administration just granted orphan drug status to ONCOFID-P for the treatment of the cancer. It is currently being studied for invasive bladder cancer, but data from lab and mice models is showing it could be beneficial for pleural mesothelioma as well. Orphan drug designation helps get companies to make new drugs for rare diseases and makes the approval process much faster.

The treatment consists of paclitaxel, a chemotherapy drug also called Taxol, and hyaluronic acid, a substance typically used with joint disorders because it has a cushioning effect. When it is combined with paclitaxel, the hyaluronic acid binds with cancer cells that express CD44, which helps with cancer cell proliferation and migration. The binding helps with intracellular concentration of the Taxol, creating a more effective treatment. It also limits systemic diffusion and toxicity of the paclitaxel resulting in patients having very little side effects when patients are administered ONCOFID-P. When it is used on pleural mesothelioma tumors, it is more effective for mass reduction compared with paclitaxel alone.

A phase I clinical trial involving ONCOFID-P for pleural mesothelioma will be announced soon. Since it is already being tested on invasive bladder cancer, researchers know the safety and efficacy of the treatment.

When a manufacturer asks to have a drug designated as an orphan drug, the FDA grants it if it meets certain criteria. The manufacturer is then given tax credits and exclusivity for an extended period of time. Some people might believe orphan drug status means the drug will be approved, but this is not the case. There is no guarantee the drug is going to be approved in the future or that it is safe and effective. Paclitaxel is approved for the treatment of lung, breast, pancreatic, and ovarian cancers and has been used experimentally with prostate, esophageal, and bladder cancers. Some peritoneal mesothelioma sufferers have been given paclitaxel after surgery with positive results.

Pleural mesothelioma needs new advances in treatment because there are not enough available to help with the disease. The most recent approval was the combination of two immunotherapy drugs Opdivo and Yervoy. Even with these treatments, there is no cure, so researchers need to find new ways to fight mesothelioma. Rare diseases like mesothelioma need these advancements and breakthroughs because without them, mesothelioma sufferers could not live longer and better lives.

“Fidia Announces The Fda Orphan Drug Designation For Oncofid For The Treatment Of Malignant Mesothelioma, The Cancer Caused By Exposure To Asbestos” Fidia (7/26/2021). [Link]
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