Venetoclax FDA approved for CLL and SLL
On 15 May 2019, the FDA approved venetoclax (Venclexta®, AbbVie/Genentech) for the treatment of adult chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients.
On 15 May 2019, the FDA approved venetoclax (Venclexta®, AbbVie/Genentech) for the treatment of adult chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) patients.
On the 2nd of May 2 2019, the FDA approved ivosidenib (Tibsovo®, Agios) as treatment for newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old and AML patients with comorbidities precluding intensive induction chemotherapy. Patients should harbour a susceptible IDH1 mutation, as per the FDA-approved Abbott RealTime™ IDH1 Assay, to be legible for ivosidenib treatment.
On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).
On 28 November 2018, the FDA approved gilteritinib (Xospata® [ASP2215], Astellas) for the treatment of adult patients with relapsed or refractory (R/R) acute myeloid leukaemia (AML) harbouring FLT3 mutations as confirmed by an FDA-approved companion diagnostic test (CDx).
On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in patients with comorbidities precluding intensive induction chemotherapy.
On 21 November 2018, the FDA approved glasdegib (Daurismo®, Pfizer) in combination with low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) in patients of 75 years or older and in patients with comorbidities contraindicating intensive induction chemotherapy.
On September 24, 2018, the US FDA granted regular approval to duvelisib (Copiktra®, Verastem) for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) after ≥2 prior therapies.
On September 13, 2018, the FDA approved moxetumomab pasudotox-tdfk (Lumoxiti®, AstraZeneca) for adult patients with relapsed or refractory (R/R) hairy cell leukaemia (HCL) who had received at minimum two prior systemic therapies, of which one a purine nucleoside analogue (PNA).
On the 11th of September 2018, the FDA updated the label of venetoclax tablets (VENCLEXTA®, Abbvie) in combination with rituximab (MabThera®, Roche) to include information about pre-treated patients with chronic lymphocytic leukemia (CLL) in the Phase III MURANO trial who had achieved Minimal Residual Disease (MRD)-negativity.
TOKYO and MUNICH and BASKING RIDGE, N.J., September 11, 2018 — The Japan Ministry of Health, Labour and Welfare (MHLW) has granted quizartinib (AC220, Daiichi Sankyo), an investigational inhibitor of FLT3, the Orphan Drug designation for the treatment of acute myeloid leukaemia (AML) harbouring FLT3-mutations.
On July 20, 2018, the US FDA approved ivosidenib (Tibsovo©, Agios Pharmaceuticals) for use in adult patients with relapsed or refractory acute myeloid leukaemia (AML) harbouring a susceptible IDH1 mutation as detected by an FDA-approved companion diagnostic (CDx) test, the Abbott RealTime IDH1 Assay.
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