For people with a rare cancer called epithelioid sarcoma, there’s exciting news: The FDA has issued its approval of a new drug, Tazverik, that may completely or partially shrink tumors during treatment for some patients.
“It has been a longstanding challenge for children and young adults with rare cancers to have access to promising new agents,” Dr. Elizabeth Raetz, director of pediatric hematology and oncology at Perlmutter Cancer Center, tells SurvivorNet. “It's really exciting that they've developed this drug.”
Information About Epithelioid Sarcoma
Read MoreThe Trial
In the trial leading up to the approval, 62 patients with metastatic or locally advanced epithelioid sarcoma received treatment with Tazverik. It measured how many patients experienced complete or partial shrinkage (by a certain amount) of their tumors during treatment (overall response rate). The overall response rate was 15%, with 1.6% of patients having a complete response and 13% having a partial response. Of the nine patients that had a response, six (67%) patients had a response lasting six months or longer.The New Approval
The FDA granted what’s called “accelerated approval” for Tazverik (its generic name is tazemetostat). The drug blocks activity of a specific enzyme, which may help keep cancer cells from growing, according to the FDA statement.
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“Accelerated approval” allows the FDA to approve drugs for serious conditions to fill an unmet need, according to the statement. Still, further clinical trials may be required.
The drug is approved for patients who are adults of young adult older than 16, whose disease has spread, and who are not eligible for what’s called “complete resection,” or complete surgical removal.
Traditional Treatment
When the disease is localized in one area of the body, “surgical removal is considered the main treatment,” according to the FDA announcement. “Chemotherapy or radiation may also be given.”
But 50% of patients have metastatic sarcoma by the time of diagnosis, meaning the disease is not localized and has spread. Even with treatment, there is a high likelihood of “regional spread,” or spreading to nearby areas.
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