In June 2025, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to MVdeltaC, a new type of pleural mesothelioma immunotherapy developed by Oncovita. This means the FDA has recognized MVdeltaC as a promising treatment for pleural mesothelioma and is offering support to help move it through testing and approval more quickly.
“This recognition highlights the promise of this novel approach against one of the most aggressive cancers in medicine,” said Dr. Stéphane Champiat, medical advisor at Oncovita.
While MVdeltaC is still in testing and not yet available to the public, this early milestone brings new hope to families facing this cancer. Learn more about how the drug works and what its FDA status could mean for patients.
How MVdeltaC Fights Mesothelioma
MVdeltaC is a genetically modified version of the measles virus that’s injected directly into tumors using a needle. It’s designed to selectively target pleural mesothelioma without harming healthy cells.
The virus enters cancer tumors using a protein called CD46, which is found in high amounts on mesothelioma cells. Once it gets inside, MVdeltaC multiplies and causes cancer cells to burst, shrinking tumors and triggering the immune system to attack any remaining cancer cells.
This two-pronged approach — directly killing cancer and boosting the immune response — is why MVdeltaC could be a game-changer in mesothelioma treatment immunotherapy.
In early animal trials, this newer form of immunotherapy shrank mesothelioma tumors by 60-70%. Even more exciting, when MVdeltaC was combined with another type of immunotherapy called a checkpoint inhibitor, the mice in the study experienced full survival (meaning their tumors completely disappeared).
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What Makes MVdeltaC Different Than Other Immunotherapies?
What makes MVdeltaC an especially promising mesothelioma treatment is its ability to convert “cold” tumors that are able to sneak past the immune system to “hot” tumors that are more responsive to immunotherapy.
MVdeltaC works by:
- Targeting a Common Weak Spot in Cancer Cells. MVdeltaC uses a specific doorway called CD46 that is more common on cancer cells than healthy ones. This allows the therapy to go straight to the tumor while leaving normal tissues unharmed, possibly leading to fewer side effects than chemotherapy.
- Killing Cancer Cells From the Inside. Once inside a cancer cell, MVdeltaC multiplies only within those cells. This causes the cells to burst open and die, helping to shrink the tumor directly.
- Waking Up the Immune System. When the cancer cells die, they release danger signals that act like an alarm. This helps train the immune system to recognize and attack similar cancer cells elsewhere in the body.
- Boosting the Power of Other Immunotherapies. MVdeltaC works exceptionally well when combined with treatments like immune checkpoint inhibitors. In lab studies, this combination has led to the complete elimination of tumors in some cases.
“Receiving orphan drug designation from the FDA for MVdeltaC marks a major milestone for Oncovita and validates our approach of harnessing the potential of measles vaccine viruses to treat rare and devastating cancers such as pleural mesothelioma,” said Stéphane Altaba, chief executive officer of Oncovita.
What FDA Orphan Drug Status Means for Mesothelioma Patients
While it doesn’t guarantee approval, orphan drug status can make it easier and faster for companies to start mesothelioma clinical trials in humans and eventually bring the drug to market if those trials are successful.
In practical terms, this could lead to:
- Faster access to a new, potentially more effective treatment
- Longer survival, especially if current therapies stop working
- Increased focus on mesothelioma research, which has historically been underfunded
- A sense of validation that people with mesothelioma matter and deserve access to better treatments
Ultimately, it offers patients and families something they deeply need: the possibility of more time, better options, and renewed hope.
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