Latest From Alaric DeArment
The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.
The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.
The dermatology specialist announced positive results from the OLYMPIA 2 trial of nemolizumab, but Sanofi and Regeneron are already pursuing a similar indication for Dupixent.
The companies published data showing the drug was effective in patients with both homologous recombinant repair mutated and non-mutated disease.
The company got FDA approval for the drug in Bardet-Biedl syndrome, on top of the existing approval from November 2020 in obesity due to POMC, PCSK1 and LEPR deficiency.
CEO Adrian Rawcliffe talked with Scrip about filing and early commercial plans for afami-cel in synovial carcinoma if it is approved by the FDA.