acute myeloid leukaemia

Kura hit as FDA slaps partial hold on leukaemia trial

Share in Kura Oncology have come under pressure after a patient death in a clinical trial of the US biotech’s acute myeloid leukaemia (AML) therapy KO-539, provisionally attributed to a side effect that plagues other drugs used to treat the cancer. The FDA has placed the trial on partial hold, meaning that patients already in …

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Gamble by Takeda on unproven cancer mechanism draws a blank

Takeda says a phase 3 trial of its cancer candidate pevonedistat – a class-leading NEDD8-activating enzyme inhibitor – has failed to show a benefit in patients with blood cancers, placing its future in doubt. The PANTHER trial looked at the combination of pevonedistat in combination with azacitidine chemotherapy as first-line treatment for patients with higher-risk …

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Servier gets a win for cancer drug Tibsovo, bought in $1.8bn Agios deal

Just three months after completing its $1.8 billion takeover of Agios’ oncology pipeline, Servier has reported positive results for lead drug Tibsovo that could expand the use of the drug in acute myeloid leukaemia. Tibsovo (ivosidenib) was already on the market when Servier made its play for Agios’ assets, having secured US approvals as a …

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J&J backs out of $1.6bn blood cancer antibody alliance with Argenx

Belgian biotech Argenx has lost its development partner for acute myeloid leukaemia antibody cusatuzumab, after Johnson & Johnson backed away from the alliance after two and a half years. J&J’s Cilag unit – part of its Janssen pharma division – said this morning that it had decided not to continue the collaboration after a “review …

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FDA grants full approval for Roche/AbbVie’s Venclexta in AML combination therapies

Combination therapies involving Roche and AbbVie’s cancer drug Venclexta have been formally approved by the FDA in acute myeloid leukaemia, following supportive data from late-stage studies. The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. But accelerated approval is only a temporary measure and …

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NICE backs NHS use for Astellas’ Xospata after rethink

NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acute myeloid leukaemia.  In final draft guidance NICE said that the drug is recommended for relapse or refractory FLT3 mutation-positive AML, giving patients an alternative to chemotherapy and its unpleasant side effects.  However because of considerable uncertainty about long-term survival after stem cell transplant, NICE …

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