The EC approved Herzuma for patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have HER2 overexpression or HER2 gene amplification.
Genentech announced results from the positive Phase III IMmotion151 study of Tecentriq (atezolizumab) and Avastin (bevacizumab) as a first-line treatment for advanced or metastatic renal cell carcinoma.
Pfizer Inc. announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera (rituximab-EU), met its primary endpoint.
Genentech announced that the U.S. FDA approved Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
Samsung Bioepis Co. Ltd. announced the European Commission’s marketing authorization of Ontruzant – a biosimilar referencing Herceptin (trastuzumab) – for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.
Janssen-Cilag International NV announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended broadening the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of prostate cancer than its current indications.
The U.S. FDA approved Genentech’s Actemra (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor T cell-induced severe or life-threatening cytokine release syndrome in patients 2 years of age and older.
AbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.
Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
