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What happens when multiple targeted therapies are approved by FDA, each with a unique companion diagnostic for the same biomarker? The health care system is ill-equipped to deal with that scenario, putting patients at risk if the wrong test is used to guide a treatment decision. Industry has one solution: an analytical comparison of various diagnostic assays, starting with the anti-PD-L1 immunotherapy class.
Allergan’s buyout of MAP Pharma is an unusual case of a deal centered on drug under the shadow of a “complete response” letter, but it’s not the only one. How does it compare to recent precedents.
The institute has come under scrutiny in the past for how it describes its investigational cancer products, but more mainstream oncology companies have also been cited for jumping the gun with promotional claims for products FDA hasn’t yet approved.
Omacetaxine finds new life as a salvage treatment in chronic myeloid leukemia after failing to pass FDA muster for targeted therapy in patients with a particular genetic mutation. FDA allowed Teva to pool data from two open-label studies to secure approval in a third-line setting.
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