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ASCO: Rusfertide Inches Toward FDA Filing With Positive 32-Week Data

 
• By Alaric DeArment

Takeda/Protagonist are awaiting 52-week data to confirm the results from the VERIFY trial of the drug in polycythemia vera.

(Alaric DeArment)

Takeda Pharmaceutical and partner Protagonist Therapeutics are now awaiting 52-week data from their registrational trial of rusfertide in polycythemia vera (PV) patients dependent on phlebotomy, after which the drug will be ready for a US Food and Drug Administration filing.

Key Takeaways
  • Takeda/Protagonist presented positive 32-week data in the plenary session at ASCO for rusfertide in polycythemia vera, highlighting findings like the lower rate of cancers in the treatment group versus the placebo arm.

The Osaka, Japan-based drugmaker and the Newark, Calif.-based biotech presented 32-week data from the Phase III VERIFY trial in the...

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Henlius CEO Details PD-L1 ADC’s Path To 1L Mono/Combo Therapy

 
• By Dexter Jie Yan

Henlius is investigating the optimum dose for its PD-L1-targeting antibody-drug conjugate HLX43 to support potential first-line use, its CEO explains to Scrip.

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The small interference RNA therapeutic can be used by patients regardless of inhibitor status.

With Phase III Success, PharmaEssentia To Seek Besremi Label Expansion (Update)

 
• By Joseph Haas

Taiwan-based PharmaEssentia hopes to add essential thrombocytopenia to the label for its pegylated interferon product, already approved to treat polycythemia vera.

Regeneron Will Move Two Factor XI Agents Into Phase III

 
• By Joseph Haas

With successful Phase II data versus active comparators for both REGN7508 and REGN9933, Regeneron hopes to position the candidates to compete against existing factor X products.