Spectrum Pharma's Rolontis Positive In Pivotal Cancer Study
Zacks Investment Research | Feb 05, 2018 10:10PM ET
Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) announced positive data from a phase III study, ADVANCE, evaluating its lead pipeline candidate, Rolontis, for management of chemotherapy-induced neutropenia in patients with early-stage breast cancer. The candidate demonstrated non-inferiority to Amgen Inc.’s (NASDAQ:AMGN) Neulasta in improving duration of severe neutropenia.
Shares of Spectrum Pharma have skyrocketed 314.8% in the past year, significantly outperforming the industry ’s gain of 2.8%.
The company is evaluating Rolontis in two phase III studies – ADVANCE and RECOVER – in early-stage breast cancer patients.
The ADVANCE study compared Rolontis to Neulasta for management of chemotherapy-induced neutropenia in breast cancer patients who received docetaxel and cyclophosphamide chemotherapy every 21 days.
With the completion of enrollment in RECOVER study, announced in the press release, Spectrum Pharma is on track to file a biologics license application seeking approval of Rolontis for management of neutropenia in the fourth quarter of 2018.
Apart from Rolontis, the company is developing Qapzola for treating non-muscle invasive bladder cancer and poziotinib in non-small cell lung cancer patients and breast cancer.
In October 2017, Spectrum announced encouraging preliminary data on poziotinib from phase II NSCLC study in patients who have exon 20 insertion mutations in EGFR.
However, Spectrum Pharma’s product sales from its six marketed products have been lacklusterin the last six months due to intense competition. This keeps investors focused on pipeline development.
Spectrum Pharmaceuticals, Inc. Price
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