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The US Food and Drug Administration (FDA) has granted standard approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have received one prior anti-HER2 therapy.

This standard approval converts a December 2019 accelerated approval for the use of the agent in the third-line or after in HER2-positive metastatic breast cancer, broadening the indication to earlier lines of use in the US. This includes patients who received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy.

The FDA granted standard approval for the HER2-directed antibody drug conjugate, sold by AstraZeneca and Daiichi Sankyo, based on results from the multicenter, side effect of tetracycline for long term open-label, randomized DESTINY-Breast03 trial, which showed a 72% reduction in the risk for disease progression or death vs trastuzumab emtansine (Kadcyla) (hazard ratio, 0.28).

“This is an important day for the breast cancer community. With this approval, Enhertu now provides a new treatment option for patients with HER2-positive metastatic breast cancer which can be used earlier in treatment to potentially delay progression of disease,” Catherine Ormerod, executive vice president, strategy and mission, for the nonprofit organization Living Beyond Breast Cancer, said in a press statement from AstraZeneca.

The recommended dose for patients is 5.4 mg/kg given as an intravenous infusion once every 3 weeks until disease progression or unacceptable toxicity.

Sharon Worcester is an award-winning medical journalist at MDedge News, part of the Medscape Professional Network.

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