Hints of a quickening emerge in accelerated approval conversions

The number of US approvals via the accelerated pathway has soared in recent years, particularly in oncology, recent Evaluate Vantage analyses have shown. And there are hints that conversions to full approval are accelerating, as suggested by the chart below. Still, two thirds of the 130 drugs approved on an accelerated basis in the last decade have yet to be converted, and more energy could be expended by the agency and sponsors alike. The data reveal some of the worst offenders, with Amag’s Makena, now owned by Covis, an extreme example. The FDA has proposed withdrawing the controversial preterm birth treatment, but foot-dragging by its owners means that it is still available. It is also notable that Tykerb and Istodax were both commercial flops, while the likes of Imbruvica and Alimta went on to become huge blockbusters. This is not to say that time to convert is always correlated with success; Imbruvica has three accelerated approvals outstanding, the first won seven and a half years ago.

The best of times and the worst of times
Product and sponsor  Setting (year of accelerated approval)  Time to convert to full approval
Quick turnarounds…
Imbruvica - Pharmacyclics* Relapsed/refractory chronic lymphocytic leukaemia (2014)  166 days 
Alimta - Lilly  1st-line non-squamous NSCLC (2018)  240 days
Jadenu Sprinkle - Novartis  Iron overload caused by blood transfusions (2017)  358 days
Took their time…
Tykerb - Glaxosmithkline** 1st-line Her2 +ve breast cancer (2010)  8.9 years
Exjade - Novartis  Iron overload in certain thalassaemia patients (2013)  7.5 years
Adcetris - Seagen Relapsed/refractory anaplastic large cell lymphoma (2011)  6.6 years
Hall of shame… 
Makena - Amag^ To reduce the risk of preterm birth (2011)  10 years and still waiting 
Istodax - Celgene^^ Relapsed/refractory peripheral T-cell lymphoma (2011)  Almost 10 years and still waiting
Ferriprox - Chiesi Iron overload in thalassaemia patients in need of additional chelation (2011)  9.5 years and still waiting
*Now owned by J&J/Abbvie; **Now owned by Novartis; ^Now owned by Covis; ^^Now owned by Bristol Myers Squibb. Source: FDA.gov. 

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