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.
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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.
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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.
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