ALERT: FDAapproves durvalumab plus chemo for biliary tract cancer. TwitteRx
It was conducted across many countries in Europe, South America, and Asia, as well as the United States. The FDA noted that trial demographics were as follows: 56% Asian persons, 37% White persons, 2% Black persons, and 4% persons of other race; 7% Hispanic or Latino persons; 50% men and 50% women; median age, 64 years ; and 47% aged 65 years or older.on days 1 and 8 of each 21-day cycle for up to eight cycles.
In addition, they were randomized to also receive immunotherapy or placebo on day 1 followed by the same dose every 4 weeks. Durvalumab or placebo was continued until disease progression or unacceptable toxicity. Treatment was permitted beyond disease progression if the patient was clinically stable and deriving clinical benefit, as determined by the investigator, the agency noted.
The results showed a statistically significant improvement in overall survival for patients who received immunotherapy in addition to chemotherapy. The median overall survival was 12.8 months with durvalumab vs 11.1 months with placebo adverse reactions were fatigue, nausea,The agency noted that the recommended durvalumab dosage is 1500 mg every 3 weeks for patients with a body weight ≥ 30 kg when given with gemcitabine and cisplatin, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity.
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