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15-11-2017 | FDA | News

approvalsWatch

FDA approvals granted for brentuximab, letermovir

medwireNews: The US Food and Drug Administration (FDA) has approved a treatment for primary cutaneous anaplastic large cell lymphoma (pcALCL), as well as a second agent to prevent cytomegalovirus infection (CMV) in patients who have undergone hematopoietic stem cell transplantation (HSCT)

Brentuximab vedotin may now be used for adults with pcALCL or CD30-expreessing mycosis fungoides who have previously used at least one systemic therapy, at a recommended intravenous dose of 1.8 mg/kg up to 180 mg over 30 minutes. Treatment may be given every 3 weeks for up to 16 cycles, or until disease progression or unacceptable toxicity.

The regular FDA approval follows results from the phase III ALCANZA study showing improved rates of objective response, complete response and progression-free survival with brentuximab vedotin for pcALCL or mycosis fungoides compared with methotrexate or bexarotene.

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The CMV DNA terminase complete inhibitor letermovir has been given Breakthrough Therapy and Orphan Drug designations for the treatment of HSCT patients who have been exposed to CMV.

The prophylactic agent was shown in a phase III trial to reduce the incidence of CMV infection in allogeneic HSCT patients compared with placebo. Letermovir may be given orally or intravenously for up to 100 days after transplantation.

However, letermovir is contraindicated in patients who are using pimozide and ergot alkaloid therapy, and in patients who are using pitavastatin or simvastatin plus cyclosporine.

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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