The FDA has approved Tudriqev (vusolimogene oderparepvec-wtpg) to treat adults with advanced skin cancer called cutaneous melanoma. It is used for cancer that cannot be removed by surgery and has gotten worse after treatment with certain immune-boosting medicines. Tudriqev is used together with another cancer medicine called nivolumab.Â
Tudriqev is a modified virus treatment. It is made from a changed herpes virus that is designed to target and kill cancer cells. Once inside the body, the virus multiplies inside tumor cells until the cells burst and die.Â
When the cancer cells break open, they release signals that wake up the body's immune system. Tudriqev also carries proteins that help attract immune cells directly to the tumor. Working together with nivolumab, it helps your body's immune system recognize and fight the cancer.Â
The FDA approved this medicine based on a clinical trial with 140 adults who had advanced melanoma that grew after previous immune treatments. In the main group of 91 patients who had the actual treatment, people received Tudriqev injections into their tumors along with nivolumab through an IV line. Researchers looked at how many patients saw their tumors shrink and how long those results lasted.Â
In the study, about 24% of patients saw their tumors shrink or disappear. For those who responded, the treatment worked for a median of 14.1 months. More than half of the people who responded kept their response for over a year.Â
The approval was granted under an accelerated program based on tumor response rates. This pathway helps bring promising treatments to patients sooner. An ongoing study will check to see if these benefits hold true over a longer time.
This medicine is injected directly into skin tumors every two weeks for eight doses. If tumors are deeper in the body, a health care provider will use special imaging tools to guide the needle. Starting at week three, you will also receive nivolumab through an IV infusion.Â
The most common side effects of Tudriqev with nivolumab include tiredness, fever, chills, nausea, diarrhea, and muscle pain. People also reported pain, redness, or swelling where the needle went in, as well as headaches, coughs, and rashes. In rare cases, injections into deep organs like the lungs can cause injury or bleeding, so your health care provider will monitor you after treatment.Â
Because Tudriqev contains a modified herpes virus, you and your caregivers must take care to avoid spreading it. Keep injection sites covered with bandages for at least 48 hours. Do not touch or scratch the treated areas, and wash your hands often. Caregivers should wear gloves when changing bandages and throw used materials away in sealed plastic bags.Â
Tell your health care provider about all your medical conditions before starting treatment. Mention if you take antiviral medicines, as they can stop Tudriqev from working properly. Both women and men who can have children should use effective birth control during treatment and for 90 days after the last dose. Women should not breastfeed during treatment and for 90 days after the final dose.
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