12/18/2018

Recent Oncology Related FDA Approvals/Changes

• FDA approved Herzuma (trastuzumab-pkrb, Celltrion Inc.) as a biosimilar to Herceptin (trastuzumab, Genentech Inc.) for patients with HER2-overexpressing breast cancer. More Information. December 14, 2018 (1)

• FDA approved romiplostim (NPLATE, Amgen Inc.) for pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. More Information. December 14, 2018 (1)

• FDA approved atezolizumab (TECENTRIQ, Genentech, Inc.), in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic non-squamous, non-small cell lung cancer (NSq NSCLC) with no EGFR or ALK genomic tumor aberrations. More Information.  December 6, 2018 (1)

• FDA approved gilteritinib (XOSPATA,  Astellas Pharma US Inc.) for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. More Information. November 28, 2018 (2)

• FDA granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or whose cancer has progressed following treatment. More Information.  November 26, 2018 (2)

• FDA granted accelerated approval to venetoclax (VENCLEXTA, AbbVie Inc. and Genentech Inc.) in combination with azacitidine or decitabine or lo w-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. More Information. November 21, 2018 (2)

• FDA approved glasdegib (DAURISMO, Pfizer Labs) in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy.  More Information. November 21, 2018 (2)