Phase III Survival Benefit Boosts Imbruvica’s Profile Ahead Of FDA’s CLL Decision
This article was originally published in The Pink Sheet Daily
RESONATE study is halted after Pharmacyclics/Janssen’s Imbruvica shows a survival benefit as a monotherapy compared to GlaxoSmithKline’s Arzerra. Analysts expect results will pave way for off-label use ahead of FDA’s approval in CLL, though a delay for official clearance is possible.
You may also be interested in...
FDA’s top cancer drug reviewer has taken to the podium to paint a picture of the next phase in cancer drug development, which includes new business models, a return to single-arm trials and a new emphasis on safety.
FDA’s approval of Bristol-Myers Squibb’s metastatic melanoma immunotherapy was granted only after looking outside the BLA for assurance that the biologic’s effect was robust and validated.
Part 2: High costs are built into the rare disease business model. Participants at a roundtable discussion led by Scrip at the J.P. Morgan Healthcare Conference talked about how much they are feeling the pressure on pricing.