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On October 22, 2021, the Swedish biotechnology company Oncopeptides AB (Nasdaq Stockholm: ONCO) announced its decision to withdraw the drug Pepaxto ® (INN melphalan flufenamide), which was launched in the U.
S.
market, for the treatment of relapsed or refractory multiple myeloma.
Increase the risk of death
.
The decision was made after FDA's interaction and dialogue
Image source: yahoo finance
Oncopeptipes AB is a pharmaceutical company specializing in targeted therapies for refractory blood diseases
.
The company's Pepaxto was approved by the FDA on February 26, 2021, for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM)
It is worth mentioning that Pepaxto is the first anti-cancer peptide drug conjugate approved by the FDA.
PDC (peptide-drug conjugate) is a peptide-conjugated drug.
) And a cytotoxic payload (payload), the homing peptide can specifically target the protein receptors overexpressed on the surface of tumor cells to deliver cytotoxins and induce tumor cell apoptosis
.
Compared with ADC drugs, PDC drugs have the advantages of small molecular weight, strong tumor penetration, low immunogenicity, large-scale synthesis, low production cost, relatively good pharmacokinetics, etc.
It is worth mentioning that Pepaxto is the first anti-cancer peptide drug conjugate approved by the FDA
Although temporarily frustrated, Oncopeptides said that it will continue to work on the further development of the company's proprietary peptide drug conjugate (PDC) platform, including next-generation drug candidates including OPD5 and OPDC3
.
The company said in a statement: "In our dialogue with the FDA, the FDA clearly does not believe that the OCEAN Phase III study meets the criteria for confirmatory studies
Oncopeptides R&D Program
Image source: Oncopeptides official website
Marty J Duvall, CEO of Oncopeptides, said: "The decision to withdraw Pepaxto from the market was a difficult decision.
It was a well-thought-out decision made out of the best consideration for patients and shareholders
.
The company now needs to "resource resources.
Jakob Lindberg, CSO of Oncopeptides, said: “Although the OCEAN data did not pass regulatory barriers to confirm accelerated approval in the United States, we still have full confidence in our scientific platform
.
” “Looking forward, we will further explore our PDC platform, and development may be right.
Oncopeptides will work with the FDA to continue to provide the drug to patients currently undergoing Pepaxto treatment
.
On April 16, 2021, the company submitted a new drug application to the European Medicines Agency (EMA), requesting conditional approval for the listing of Pepaxto in the EU.
The company said it is still waiting and expects results in the second quarter of next year.
Reference materials:
Reference materials:https://
