US FDA Onc\Haem Approvals – Page 3 – Medical News Asia

Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

27 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Paediatric/by scienterrific

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).

Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer

22 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Gynaecological Cancer, Oncology, Targeted Therapies/by scienterrific

On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm).

Trastuzumab-biosimilar Herzuma® FDA approved in HER2+ breast cancer

21 December 2018/0 Comments/in Breast Cancer, US FDA Onc\Haem Approvals, Oncology, Targeted Therapies/by scienterrific

On 14 December 2018, the FDA approved the Herceptin®-biosimilar Herzuma® (trastuzumab-pkrb, Celltrion), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer. Herzuma® was approved as biosimilar, not as an interchangeable product.

Frontline atezolizumab plus bevacizumab and chemotherapy FDA approved for metastatic non-squamous NSCLC

11 December 2018/0 Comments/in US FDA Onc\Haem Approvals, Lung Cancer, Oncology, Chemotherapy, Immunotherapy, Targeted Therapies/by scienterrific

On 6 December 2018, the FDA approved atezolizumab (Tecentriq®, Roche/Genentech) plus bevacizumab and chemotherapy with paclitaxel and carboplatin for the frontline treatment of metastatic non-squamous non-small cell lung cancer (NSq NSCLC) patients not harbouring any EGFR or ALK genomic tumour aberrations.

Gilteritinib (Xospata®) FDA approved for relapsed or refractory AML harbouring FLT3 mutations

29 November 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Targeted Therapies/by scienterrific

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).

TKR inhibitor larotrectinib (Vitrakvi®) FDA approved for cancers with NTRK gene fusion

28 November 2018/0 Comments/in US FDA Onc\Haem Approvals, Head and Neck Cancer, Targeted Therapies/by scienterrific

On 26 November 2018, the FDA granted accelerated approval to the first-in-class tropomyosin receptor-kinase (TRK) inhibitor larotrectinib (Vitrakvi®, Loxo Oncology/Bayer) for the treatment of adult and paediatric patients with solid tumours that are metastatic or not amenable to surgery, harbour the neurotrophic receptor tyrosine kinase (NTRK) gene fusion in the absence of known acquired resistance mutations, and whose cancer progressed following treatment or for whom are no satisfactory other treatment options available.

FDA Approves Truxima as Biosimilar to Rituxan

28 November 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Oncology, Chemotherapy, Targeted Therapies/by Stijn van den Borne, MSc

Venetoclax plus azacitidine, decitabine, or low-dose cytarabine FDA approved in elderly AML patients

23 November 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Chemotherapy, Targeted Therapies/by scienterrific

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.

Glasdegib plus low-dose cytarabine (LDAC) approved in elderly AML patients

23 November 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology, Chemotherapy, Targeted Therapies/by scienterrific

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.

Emapalumab FDA approved in adult and paediatric patients with primary hemophagocytic lymphohistiocytosis

21 November 2018/0 Comments/in US FDA Onc\Haem Approvals, Haematology/by scienterrific

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.