Category: acute myeloid leukaemia

  • EHA: Survival data sets Daiichi Sankyo’s quizartinib back on track

    Three years after Daiichi Sankyo’s FLR3 inhibitor quizartinib was rejected by the FDA, the drugmaker has reported the results of a new phase 3 trial that is key to getting the drug to the US market and chasing down rival drugs from Astellas and Novartis. Data from the QuANTUM-First trial presented at the EHA congress […]

  • FDA clears new first-line use for Servier’s Tibsovo in AML

    Servier is on course to get a return on its $1.8 billion takeover of Agios Pharma’s oncology business after getting a key FDA approval for Tibsovo, the main asset in the deal. The US regulator has approved Tibsovo (ivosidenib) in combination with Bristol-Myers Squibb’s chemotherapy Vidaza (azacitidine) as a first-line therapy for IDH1-mutated acute myeloid […]

  • Nkarta leaps on early CAR-NK data in blood cancers

    Shares in Nkarta more than doubled yesterday on the results of early-stage clinical that suggested it could be on to a winner with its natural kill (NK) cell therapy platform. The two phase 1 trials of the California biotech’s lead CAR-NK candidates showed that the therapies were able to induce complete responses in two groups […]

  • Blue Note leukaemia DTx gets FDA breakthrough tag

    A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. The DTx, called BNT200, is described as a first-of-its-kind DTx to treat anxiety and depression in adults with acute myeloid leukaemia (AML) who are hospitalised for a regimen of high-intensity induction chemotherapy. Breakthrough […]

  • BMS cuts $3.15bn deal with Century for cancer cell therapies

    Bristol-Myers Squibb chief executive Giovanni Caforio has promised to invest in the company’s pipeline at the virtual JP Morgan Healthcare Conference, and demonstrated that commitment by licensing up to four cancer cell therapy candidates from Century Therapeutics. BMS is paying $150 million upfront in cash and equity to kick off the alliance with another $3 […]

  • ASH: Servier’s Tibsovo poised for first-line used in AML

    Servier has revealed the full data from its phase 3 trial of Tibsovo as a first-line treatment for acute myeloid leukaemia that it teased in the summer, and the results look good with a big impact recorded on patient survival. The AGILE trial, which compared the combination of Tibsovo (ivosidenib) and Bristol-Myers Squibb’s chemotherapy Vidaza […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]