Oncopeptides and Vector Pharma FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East and North Africa
More than a year after the FDA called on Oncopeptides to withdraw Pepaxto (melphalan flufenamide), the Swedish company has finally lost its appeal, and the FDA is withdrawing the drug. Pepaxto initially won an accelerated approval in 2021 as a fifth-line therapy for the blood cancer known as multiple myeloma.
FDA’s Center for Drug Evaluation and Research is objecting to Oncopeptides’ appeal of the agency’s request to withdraw its cancer drug Pepaxto.
STOCKHOLM, Dec. 7, 2022 /PRNewswire/ -- Oncopeptides AB (publ) (NASDAQ Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto® (melphalan flufenamide, also called melflufen). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator drug pomalidomide for large relevant patient groups.
STOCKHOLM, Nov. 11, 2022 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that Pepaxti® (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK.
Oncopeptides has delivered some positive results from a small phase 3 study, but the data will unlikely be able to sway the FDA, CEO said.
Oncopeptides`s Pepaxti (melphalan flufenamide) Receives Approval in Europe
STOCKHOLM, Jan. 13, 2022 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma (RRMM) that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN study was initiated in 2017 and includes 495 patients from 108 hospitals in 21 countries across Europe, North America, and Asia.
STOCKHOLM, Dec. 10, 2021 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the company will present three posters on melflufen (INN melphalan flufenamide) at the Annual American Society of Hematology Meeting, ASH, on December 11-14, in Atlanta, Georgia, USA.
STOCKHOLM, Oct. 22, 2021 /PRNewswire/ -- Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the company has decided to withdraw Pepaxto® (INN melphalan flufenamide) from the market in the US, following the phase 3 OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the US Food and Drug Administration, FDA. Pepaxto was granted accelerated approval on February 26th 2021.