Skip to main content

01-02-2023 | FDA | News


FDA approves elacestrant, adds indication for pembrolizumab

Author: Shreeya Nanda


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.


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.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group