Pharma Business - August 31, 2020
Oncopeptides’ melflufen granted Priority Review
The US Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application seeking approval of melflufen in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody. The FDA has […]
Clinical Trials - August 11, 2020
Oncopeptides initiates the first study with melflufen outside multiple myeloma
Oncopeptides has announced that the first patient has been enrolled in the Immunoglobulin Light Chain (AL) amyloidosis (OP-201) study. This open-label, phase 1/2 study of melflufen and dexamethasone for patients with AL amyloidosis, following at least one prior line of therapy, is the first study to explore the effect of melflufen outside of multiple myeloma. […]
Clinical Trials - August 10, 2020
Oncopeptides starts the phase 2 PORT study
Oncopeptides has announced that the first patient has been enrolled in the phase 2 PORT study. The study, which is expected to be fully recruited in December 2020, is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen in combination with dexamethasone in patients with […]
Pharma Business - June 30, 2020
Oncopeptides takes over Kancera facility and submits NDA
Oncopeptides has agreed with Kancera to take over Kancera’s drug development facility in Solna, Sweden. The agreement is an important step in the development of Oncopeptides’ pre-clinical operations and marks an additional reinforcement of the company’s research capacity, it states. Oncopeptides recruits several employees with pre-clinical expertise from Kancera and takes over the lease contract […]
Clinical Trials - June 16, 2020
Positive results from Oncopeptides
Oncopeptides has announced that the full top-line results from the phase 2 HORIZON study, evaluating intravenous melflufen in combination with dexamethasone in patients with relapsed refractory multiple myeloma (RRMM), have been presented at the ongoing 25th European Hematology Association meeting, EHA. The results support the NDA submission to the US Food and Drug Administration, FDA, […]
Clinical Trials - June 3, 2020
Oncopeptides completes Phase 3 study enrollment
Oncopeptides has announced completion of enrollment in the phase 3 study OCEAN for the treatment of relapsed refractory multiple myeloma. The study includes 450 patients from more than 100 hospitals around the world. Results are expected to be presented later this year. About the OCEAN study OCEAN is a randomized, comparative study between melflufen and […]
