Clinical Trials - August 2, 2021
Oncopeptides announces regulatory update from the FDA
The US Food and Drug Administration, FDA, has issued a safety alert to patients and health care professionals, regarding an increased risk of death associated with Pepaxto (melphalan flufenamide), in the OCEAN study. The company has an ongoing dialogue with the FDA and will provide updated information as soon as more information becomes availabl, it […]
Clinical Trials - July 13, 2021
Oncopeptides’ announces updated trial results
Oncopeptides has announced updated results and safety measures based on the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma who have received 2 – 4 prior lines of therapy. The randomized study was initiated in 2017 and includes […]
Clinical Trials - June 6, 2021
Oncopeptides announces results from the OCEAN study
Oncopeptides have announced positive results from the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen versus pomalidomide in patients with relapsed refractory multiple myeloma. The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. “By demonstrating that melflufen is […]
Biotech Business - April 19, 2021
Oncopeptides submits application for conditional marketing authorization of melflufen in the EU
Oncopeptides has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the phase 2 HORIZON study in relapsed refractory multiple myeloma. Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines. “Following […]
Pharma Business - March 23, 2021
Oncopeptides’ PEPAXTO included in new Multiple Myeloma guidelines
Oncopeptides announces that PEPAXTO (melphalan flufenamide) has been included in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network (NCCN) in Oncology. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who […]
In a new job - March 10, 2021
Oncopeptides strengthens its leadership teams
Oncopeptides strengthens the leadership of its European operations by appointing Andrea Passalacqua as General Manager in Europe, and Pamela Bacon as Head of Medical Affairs Europe. Paula Boultbee, Chief Commercial Officer since 2016, has decided to retire after 30 years in leading oncology marketing roles. Paula played an instrumental role early in the company’s commercial […]
