Will Progression-Free Survival Cut It In Brave New Melanoma World?
The changing landscape for melanoma drugs raises questions about the appropriateness of overall survival as a trial endpoint and the ethics of using old drugs like the chemotherapy dacarbazine as “standard of care” comparators in pivotal studies.
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With Bristol-Myers Squibb Co.’s ipilimumab cleared and Roche/Daiichi Sankyo’s BRAF inhibitor vemurafenib (RG7204) on track for a filing and perhaps approval this year, companies developing other melanoma drugs face a more complicated, competitive path to market.
Drug makers responding to FDA's draft guidance on co-development of novel drugs to be used in combination asked the agency to loosen up the boundaries on what kinds of products can be combined, particularly in light of the requirement that the products be aimed only at serious and life-threatening diseases for which there are no satisfactory alternatives.
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.