medwireNews: The US FDA has approved elacestrant for advanced breast cancer and also allowed the adjuvant use of pembrolizumab for resectable non-small-cell lung cancer (NSCLC).
The oral selective estrogen receptor degrader (SERD) elacestrant should be given to postmenopausal women or adult men with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed after one or more lines of endocrine therapy, states the FDA.
The efficacy of elacestrant was assessed in the phase 3 EMERALD trial, which demonstrated significantly longer progression-free survival for patients who received the SERD than for those given fulvestrant or an aromatase inhibitor.
According to the prescribing information, elacestrant should be taken with food at a daily dose of 345 mg until disease progression or unacceptable toxicity.
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The regulatory agency has extended the indication for pembrolizumab to include the adjuvant treatment of adults with NSCLC who have undergone resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA disease.
This approval is based on the phase 3 KEYNOTE-091 study that met its primary endpoint of significantly better disease-free survival with pembrolizumab versus placebo in patients with resectable NSCLC.
The recommended dose of the PD-1 inhibitor is 200 mg every 3 weeks or 400 mg every 6 weeks for up to a year or until disease recurrence or unacceptable toxicity.
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