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On 4 April 2019, the US FDA approved palbociclib (Ibrance®, Pfizer) plus aromatase inhibitor or fulvestrant for the treatment of male patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
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 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
On the first day of the 2018 American Society of Hematology (ASH) Annual Meeting, an additional year of follow-up data from the practice-changing MURANO study were presented to the audience by Professor John F. Seymour. In the trial’s setting of relapsed/refractory (R/R) chronic lymphocytic leukaemia (CLL), the non-chemo-containing regimen venetoclax (Venclexta®, AbbVie/Roche) plus rituximab was associated with maintained superior progression-free survival (PFS) and overall survival (OS) over standard-of-care chemoimmunotherapy with bendamustine plus rituximab. At the same time, a durable post-treatment disease control is also attainable with the fixed-duration chemo-free regimen.
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 20 November 2018, the FDA approved the interferon-γ neutralising monoclonal antibody emapalumab (Gamifant®, Novimmune) for the treatment of adult and paediatric (newborn and older) patients with refractory, recurrent, or progressive primary haemophagocytic lymphohistiocytosis (HLH) or in patients intolerant to conventional HLH therapy.
On 16 November, 2018, the FDA approved brentuximab vedotin (Adcetris®, Seattle Genetics) in combination with chemotherapy for the treatment of previously untreated systemic anaplastic large cell lymphoma (sALCL) and other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS).
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