Spectrum Pharmaceuticals Presents FDA with Phase 2 Breast Cancer Protocol

Spectrum Pharmaceuticals (NasdaqGS:SPPI) has presented the FDA with Phase 2 breast cancer study protocol to initiate a new study as soon as possible.
According to the press release:

“This Phase 2 study is an important step for us to solidify our registration strategy in the U.S.,” said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. “The potential target market for Poziotinib is large, and metastatic breast cancer patients continue to progress despite availability of several drugs. Poziotinib has shown promising early clinical activity in Phase 1 trials in patients who had failed multiple lines of treatment including the HER2-directed therapies, trastuzumab and lapatinib. The U.S. Phase 2 trial was designed based on learnings from Phase 1 and Hanmi’s ongoing Phase 2 trials in Korea. We are planning a fast to market strategy as a single agent in parallel with the development of a broader indication using poziotinib in combination with other approved therapies for use in earlier stage disease.”
The Phase 2 study is planned to be an open-label study that will enroll approximately 70 patients with HER-2 positive metastatic breast cancer, who have failed at least one or more HER-2 directed therapy. The dose and schedule of oral poziotinib will be based on clinical experience from the studies in Korea, and in addition include the use of prophylactic therapies to help minimize known side-effects of HER2-directed therapies.

Click here to read the full press release.