Phase 3 study of REOLYSIN in combination with paclitaxel, for the treatment of hormone receptor positive, HER2 receptor negative (HR+/HER2-) metastatic breast cancer (mBC) patients
Phase of Trial: Phase III
Latest Information Update: 10 May 2018
At a glance
- Drugs Pelareorep (Primary) ; Paclitaxel
- Indications Advanced breast cancer
- Focus Registrational; Therapeutic Use
- Sponsors Oncolytics Biotech
- 10 May 2018 According to an Oncolytics Biotech media release, the company has reached an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the company's phase 3 study evaluating pelareorep for the treatment of metastatic breast cancer
- 09 Mar 2018 Planned number of patients changed from 400 to 450, according to an Oncolytics Biotech media release.
- 09 Mar 2018 According to an Oncolytics Biotech media release, company has discussed about this study at the End-of-Phase 2 meeting with the FDA, with subsequent increase in the planned patient No to 450. Also, company received a Final Advice Letter from the EMA suggesting that this study is basis of a Marketing Authorization Application (MAA) in Europe.