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Oncopeptides AB

http://www.oncopeptides.se/

Latest From Oncopeptides AB

Pepaxto Adcom Saw Public Airing Of Unusual Level Of Discord Between US FDA, Oncopeptides

The four-hour virtual public meeting featured "incompatible" views of the FDA and sponsor on the OCEAN data, not to mention signs of impatience and resentment, with each side criticizing the positions of the other over the safety and efficacy of the multiple myeloma drug.

Advisory Committees Post Market Regulation & Studies

Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL

In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Advisory Committees Post Market Regulation & Studies

Oncopeptides’ Pepaxto Needs New Study To Identify Population That Will Benefit, FDA Panel Says

Advisory committee votes 14-2 that melflufen’s benefit-risk profile is unfavorable in the current accelerated approval indication for fifth-line treatment of multiple myeloma; panel rejects sponsor’s attempt to rely on post hoc analyses to 'carve out' a subpopulation that, it asserts, is responsible for negative overall survival trend in OCEAN confirmatory trial.

Advisory Committees Post Market Regulation & Studies

US FDA Panel To Weigh Whether Copiktra’s Benefit-Risk Profile In Hematologic Cancers Has Changed

Adverse trend in overall survival, tolerability concerns, and uncertainty regarding the dose suggest the PI3K inhibitor's benefit-risk profile in its current indications is unfavorable, FDA says. Secura Bio asserts OS data are confounded and safety issues are the same as at initial approval.

Advisory Committees Drug Review
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