CHMP wants to expand use of BV to include CTCL

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Micrograph showing
mycosis fungoides
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the approved indication for brentuximab vedotin (BV, Adcetris). The CHMP is recommending authorization of BV to treat adults with CD30+ cutaneous T-cell lymphoma (CTCL) who have received at least 1 prior systemic therapy. The... [Read Article]
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FDA approves brentuximab vedotin for pcALCL, MF

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Brentuximab vedotin
Photo from Business Wire
The US Food and Drug Administration (FDA) has expanded the approved use of brentuximab vedotin (BV, ADCETRIS). BV is now approved for adults with primary cutaneous anaplastic large-cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. This is the fourth FDA-approved indication for... [Read Article]
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Ibrutinib sustains efficacy in CLL at 4-year follow-up

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Ibrutinib (Imbruvica)
Photo courtesy of Janssen
The 4-year follow-up of the RESONATE trial suggests ibrutinib may provide long-term efficacy in previously treated patients with chronic lymphocytic leukemia (CLL). The median progression-free survival (PFS) has not yet been reached in this trial, regardless of high-risk cytogenetics, according to Jennifer Brown, MD, PhD, of the Dana-Farber... [Read Article]
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FDA approves drug to treat rel/ref MCL

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Acalabrutinib (Calquence)
Photo from AstraZeneca
The US Food and Drug Administration (FDA) has granted accelerated approval to the BTK inhibitor acalabrutinib (Calquence, formerly ACP-196). The drug is now approved to treat adults with mantle cell lymphoma (MCL) who have received at least 1 prior therapy. The FDA’s accelerated approval pathway is used for... [Read Article]
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EMA recommends orphan designation for G100 to treat FL

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Micrograph showing
follicular lymphoma
The European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products has recommended orphan designation for G100 for the treatment of follicular lymphoma (FL). G100 contains the synthetic small molecule toll-like receptor-4 agonist glucopyranosyl lipid A. G100 works by activating innate and adaptive immunity in the tumor microenvironment to generate... [Read Article]
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