Resources for Food and Drug Administration (FDA)
FDA Approves Oral Agent for Relapsed Small-Cell Lung Cancer
www.medpagetoday.com The FDA has approved topotecan (Hycamtin) capsules for treatment of relapsed small cell lung cancer (SCLC), GlaxoSmithKline has announced.
Specifically, the capsules are indicated for patients who had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment.
The company said topotecan capsules are the only oral single-agent chemotherapy approved for the treatment of SCLC after failure of first-line therapy.
This approval was based on a phase III study comparing topotecan capsules plus best supportive care to best supportive care alone in patients with relapsed SCLC who were not suitable candidates for IV therapy.
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