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Jul
These data suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus. Patients with small cell lung cancer and disease progression after one to two prior chemotherapy regimens were randomized 3:2 to nivolumab 3 mg/kg every 2 weeks or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four cycles followed by nivolumab 3 mg/kg every 2 weeks.
In consultation with the fda, bristol myers.
Nivolumab in small cell lung cancer. Patients were stratified by number of prior chemotherapy regimens and treated. It’s for people with sclc that has metastasized (spread to other parts of the body) and has continued to get worse after being treated with at least 2 types of therapy including. Nivolumab monotherapy and nivolumab plus ipilimumab showed antitumour activity with durable responses and manageable safety profiles in previously treated patients with sclc.
Horn l, spigel dr, vokes ee, et al. In 2018, opdivo (nivolumab) was granted accelerated approval by the u.s. The response rate was 20%.
Bristol myers squibb, in consultation with the food and drug administration (fda), has decided to withdraw the indication for opdivo (nivolumab) for the treatment of patients with small cell lung. Patients with small cell lung cancer and disease progression after one to two prior chemotherapy regimens were randomized 3:2 to nivolumab 3 mg/kg every 2 weeks or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four cycles followed by nivolumab 3 mg/kg every 2 weeks. The accelerated approval was based on opdivo’s effect on surrogate endpoints from the phase.
At 1 year, the overall survival rate was 42% (95% ci, 34 to 50) with nivolumab versus 24% (95% ci, 17 to 31) with docetaxel. Gettinger sn, horn l, gandhi l, et al. The us food and drug administration had approved the immunotherapy drug opdivo (nivolumab) to treat people with small cell lung cancer (sclc).
These data suggest a potential new treatment approach for a population of patients with limited treatment options and support the evaluation of nivolumab and nivolumab plus. The following pieces of evidence underscored the rationale for investigating nivolumab and nivolumab plus ipilimumab in sclc: This is the first immunotherapy drug approval for sclc.
In consultation with the fda, bristol myers.