Fourth Trastuzumab Biosimilar Granted FDA Approval – Drug for nerve pain boosts high for opioid abusers.

16511-pharmacy-board-standard-041216Aabama Defense Lawyer, Board of Pharmacy, Pharmacy Defense Attorney, KLF

Fourth Trastuzumab Biosimilar Granted FDA Approval – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889

Officials with the FDA have approved trastuzumab-qyyp (Trazimera, Pfizer), a biosimilar to trastuzumab (Herceptin), according to a press release.1

Trastuzumab is indicated for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The agency’s approval of trastuzumab-qyyp was based on data, including results from the REFLECTIONS B327-02 trial, that showed a high degree of similarity between trastuzumab-qyyp and the originator product. In the study, trastuzumab-qyyp showed clinical equivalence and no clinically meaningful differences compared with the reference product in patients with first-line HER2 overexpressing metastatic breast cancer. As part of the REFLECTIONS clinical trial program, trastuzumab-qyyp has been studied in approximately 500 patients.1

CLICK HERE FOR CONTINUE READING

This entry was posted in Pharmacist and tagged , , , . Bookmark the permalink.

Comments are closed.