Tecentriq was approved by the FDA for adults and children aged two years and older with advanced alveolar soft part sarcoma, a disease typically diagnosed in approximately 80 patients per year in the U.S.
The Food and Drug Administration (FDA) has approved the monoclonal antibody Tecentriq (atezolizumab) for the treatment of adults and children aged two years and older with unresectable or metastatic alveolar soft part sarcoma.
Alveolar soft part sarcoma is a rare cancer that is diagnosed in approximately 80 patients each year in the United State and is most commonly seen in young adults, according to a press release from Genentech, the manufacturer of the drug.
“This approval brings new hope for children, adults and their families affected by advanced alveolar soft part sarcoma who historically have had very limited treatment options,” said Dr. Levi Garraway, chief medical officer and head of global product development for Genentech, in the release.
This FDA approval was based on findings from Study ML39345, which included 49 adults and children with unresectable or metastatic alveolar soft part sarcoma. In particular, the median age of patients in this study was 31 years, with 47 adults and two children.
Patients were treated intravenously with Tecentriq once every 21 days until disease progression or unacceptable toxicity, according to a release form the FDA.
The overall response rate (percentage of patients with a partial or complete response to treatment) was 24%. Of the 12 patients with a measurable response to the treatment, 67% of them had a duration of response (the time from treatment to disease progression or death in patients who had a complete or partial response to treatment) of six months or more, and 42% of patients had a duration of response of 12 months or more.
The most common side effects, occurring in at least 15% of patients in the study, included fatigue (55%), musculoskeletal pain (67%), cough (45%), rash (47%), nausea (43%), high blood pressure (43%) and headache (43%), according to the FDA’s release. Other side effects included constipation (33%), shortness of breath (33%), vomiting (37%), anxiety (25%), fever (25%), abdominal pain (25%) and hyperthyroidism (25%), among other side effects.
According to the FDA, the recommended dose of Tecentriq for adults is 840 milligrams every two weeks, 1,200 milligrams every three weeks or 1,680 milligrams every four weeks until disease progression or unacceptable toxicity. For children ages two years and older, the recommended dose is 15 milligrams/kilogram (with a maximum of 1,200 milligrams) every three weeks until disease progression or unacceptable toxicity.
Alveolar soft part sarcoma is a rare disease often diagnosed at advanced stages in young adults, can spread slowly but relentlessly over time and can return after surgery, according to the release from Genentech. Approximately 20% of patients diagnosed with advanced alveolar soft part sarcoma live for five years or longer, according to the release.
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