Oncopeptides AB, a biotech company focused on difficult-to-treat cancers, and Vector Pharma FZCO (Vector) jointly announced a collaboration to commercialize Oncopeptides’ flagship drug Pepaxti (melphalan flufenamide) in the Middle East and North Africa (MENA) countries of Saudi Arabia, Qatar, UAE, Bahrain, Kuwait, Oman, Algeria, Tunisia, Morocco, Libya, Lebanon and Iraq.
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.
Oncopeptides’ appeal to the FDA’s withdrawal proposal for the blood cancer drug Pepaxto has been made public, shedding new light on the seesawing that’s been going on at the Swedish biotech.
The FDA’s new, expedited process around accelerated approval withdrawals will be put to its first test with Oncopeptides’ 2021 accelerated approval of Pepaxto (melphalan flufenamide), which first won approval as a fifth-line therapy for the blood cancer known as multiple myeloma, but failed its confirmatory trial.
Almost three months after Swedish authorities first arrested Oncopeptides chief scientific officer Jakob Lindberg, they’ve closed their investigation, the biotech says.
Oncopeptides chief scientific officer Jakob Lindberg was arrested in Sweden on Wednesday morning on allegations he passed insider information to an individual outside the company.
STOCKHOLM, Jan. 18, 2023 /PRNewswire/ -- Oncopeptides AB (publ.) (NASDAQ Stockholm: ONCO), a biotech company focused on commercialization, research, and development of therapies for difficult-to-treat hematological diseases, today announces that Holger Lembrer, who recently was appointed Chief Financial Officer, CFO, takes the office on January 18.
Two biotechs are shuffling their C-suites as the calendar turns to the new year: Oncopeptides and Zymeworks.
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.