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23-12-2020 | FDA | News


FDA announces breast, lung, prostate cancer approvals

Author: Shreeya Nanda


medwireNews: The US FDA has issued positive decisions for the use of margetuximab-cmkb in breast cancer, adjuvant osimertinib in lung cancer, and relugolix in prostate cancer.

The anti-HER2 monoclonal antibody margetuximab, given alongside chemotherapy, is indicated for adults with metastatic HER2-positive breast cancer who have received at least two previous HER2-directed therapies, of which one must have been given in the metastatic setting.

The decision follows on from the SOPHIA trial showing significantly improved progression-free survival when margetuximab rather than trastuzumab was used alongside chemotherapy in this patient population.

Margetuximab should be given at a dose of 15 mg/kg every 3 weeks, administered intravenously over 120 minutes for the first dose and over a minimum of 30 minutes for subsequent doses. The agent can be given straight after chemotherapy on days when both are to be administered.


Osimertinib can now be used for the adjuvant treatment of patients with early-stage non-small-cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations, as identified by an FDA-approved test.

The third-generation EGFR inhibitor achieved significantly better disease-free survival than placebo in the ADAURA trial comprising individuals with resectable stage IB–IIIA tumors.

The recommended dose of osimertinib in the adjuvant setting is 80 mg/day, to be given for up to 3 years in the absence of disease progression or unacceptable toxicity.


The FDA has permitted the use of relugolix for the treatment of advanced prostate cancer, making it the first oral gonadotropin-releasing hormone receptor antagonist to be approved in the USA.

The agent was investigated in the HERO study, which recruited men with newly diagnosed or recurrent castration-sensitive advanced disease and showed a significantly improved sustained castration rate with relugolix versus leuprolide.

It is recommended that relugolix be administered at a loading dose of 360 mg/day, followed by a daily dose of 120 mg. The drug should be taken with or without food at around the same time each day.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2020 Springer Healthcare Ltd, part of the Springer Nature Group


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