Weighing the costs of CAR T-cell therapy

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Tisagenlecleucel (Kymriah)
Photo from Novartis
The cost-effectiveness of tisagenlecleucel (Kymriah) depends on long-term clinical outcomes, which are presently unknown, according to investigators. If the long-term outcomes are more modest than clinical trials suggest, then payers may be unwilling to cover the costly therapy, reported John K. Lin, MD, of Stanford University, and his colleagues. Lowering... [Read Article]
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Carfilzomib receives approval for once-weekly dosing

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Carfilzomib (Kyprolis)
Photo courtesy of Amgen
The U.S. Food and Drug Administration (FDA) has approved carfilzomib (Kyprolis) for a once-weekly dosing option in combination with dexamethasone for patients with relapsed or refractory multiple myeloma (MM). Carfilzomib administered once-weekly at 70 mg/m2 with dexamethasone achieved a superior progression-free survival (PFS) and overall response rates (ORR) compared... [Read Article]
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Blinatumomab approved to treat ALL in Japan

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Vials of blinatumomab powder
and solution for infusion
Photo courtesy of Amgen
The Japanese Ministry of Health, Labour and Welfare has approved blinatumomab (Blincyto®) for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL). Blinatumomab is the first and only bispecific T-cell engager immunotherapy construct approved globally. The drug’s approval in Japan... [Read Article]
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FDA approves duvelisib for CLL/SLL and FL

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Micrograph showing CLL
The U.S. Food and Drug Administration (FDA) has approved duvelisib (Copiktra™), a dual PI3K delta/gamma inhibitor, for two indications. Duvelisib has full FDA approval to treat adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies. Duvelisib also has accelerated approval to... [Read Article]
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Drug approved as part of frontline therapy for HL

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Brentuximab vedotin
Photo from Business Wire
The Japanese Ministry of Health, Labour and Welfare has approved brentuximab vedotin (Adcetris) in combination with doxorubicin, vinblastine, and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma (HL). The approval was based on the phase 3 ECHELON-1 trial. Result from ECHELON-1 were presented at the 2017 ASH... [Read Article]
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CHMP reconsiders new indication for blinatumomab

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Vials of blinatumomab powder
and solution for infusion
Photo courtesy of Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) said it will re-examine a recent opinion on blinatumomab (Blincyto). In July, the CHMP recommended against approving blinatumomab to treat patients with B-cell precursor acute lymphoblastic leukemia (BCP-ALL) who have minimal... [Read Article]
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CHMP backs proposed biosimilars of pegfilgrastim

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Neulasta Onpro Kit
Photo from Amgen
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for three proposed biosimilars of pegfilgrastim—Ziextenzo, Pelmeg, and Fulphila. If approved by the European Commission (EC), these products would be used for the same indication as the reference medicine, Neulasta (pegfilgrastim). Neulasta has been... [Read Article]
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CHMP recommends factor VIII therapy for hemophilia A

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U.S. version of damoctocog alfa pegol (Jivi®)
Photo from Bayer
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for damoctocog alfa pegol, a recombinant human factor VIII therapy. Bayer is seeking European marketing authorization for damoctocog alfa pegol (formerly BAY94-9027), for the treatment and prophylaxis of... [Read Article]
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CHMP supports new indication for venetoclax

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U.S. version of venetoclax
Photo courtesy of Abbvie
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) approve a new indication for venetoclax (Venclyxto®). AbbVie is seeking EC approval for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic... [Read Article]
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CHMP recommends mogamulizumab for MF, SS

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Micrograph showing
mycosis fungoides
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for mogamulizumab (Poteligeo). Kyowa Kirin Limited is seeking European Commission (EC) approval for mogamulizumab as a treatment for adults with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic... [Read Article]
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