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08-05-2017 | FDA | News | Article

approvalsWatch

Brigatinib, durvalumab given FDA approval for new indications

medwireNews: Brigatinib has received accelerated approval from the FDA for the treatment of metastatic non-small-cell lung cancer that has tested positive for the anaplastic lymphoma kinase (ALK) rearrangement.

The oral tyrosine kinase inhibitor may now be used at a recommended dose of 90 mg/day in patients who have previously progressed on, or are intolerant to, crizotinib therapy.

But patients should be monitored for a range of side effects, including respiratory and visual symptoms, hypertension, bradycardia, and elevations in amylase, lipase, blood glucose and creatinine phosphokinase. Serious adverse events should be reported to the FDA MedWatch Reporting System.

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Durvalumab has been granted accelerated approval for patients with locally advanced or metastatic urothelial carcinoma that has progressed during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

The monoclonal antibody targeting programmed cell death ligand-1 (PD-L1) was also given priority review and Breakthrough Therapy Designation, while the VENTANA PD-L1 assay was approved as a complementary diagnostic for the agent using paraffin-embedded urothelial tumor tissue.

The recommended durvalumab dose is 10 mg/kg given as a 60-minute intravenous infusion every 2 weeks until disease progression or unacceptable toxicity.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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