Kymriah (tisagenlecleucel) became the first gene therapy available in the United States.
FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones. Verzenio, sponsored by Eli Lilly, is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread.
FDA has approved Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Amgen has reached a global settlement with AbbVie to resolve all pending litigation regarding Amgevita/Amjevita, a biosimilar to AbbVie's Humira (adalimumab).
FDA approved a new label for Odomzo (sonidegib), an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
The European Commission has approved AVEO Oncology's Fotivda (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.
The European Commission approved Rydapt (midostaurin) for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive.
FDA approved a lower dose of Jevtana (cabazitaxel, 20 mg/m2 every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010.
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for Tesaro's marketing authorization application for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response or partial response to platinum-based chemotherapy. This opinion will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union. Pending the decision by the EC, Zejula would be the first oral, once-daily poly (ADP-ribose) polymerase 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
Bristol-Myers Squibb Co. said the Japanese Ministry of Health, Labor, and Welfare has approved Opdivo (nivolumab) for unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy.
