At a recent forum in Seoul, an executive of Hanmi Pharmaceuticals, whose novel neutropenia drug has just received a US green light, shares why it is crucial to create "blue oceans" through global innovative drug development and how the Korean firm plans to challenge these markets.

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.

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

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.